Efficacy of a Unani formulation in Nazla Haar

Efficacy of a Unani formulation in Nazla Haar

By

A.H. AYSHAH FAZEENAH

Dissertation submitted to the

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

In partial fulfillment

of the requirements for the degree of

MAHIRE TIB (MD Unani)

in

MOALAJAT (Medicine)

Under the guidance of

Dr. Mohd. Aleemuddin Quamri

Department of Moalajat National Institute of Unani Medicine

Bangalore 2012

ii

Rajiv Gandhi University of Health Sciences, Karnataka

DECLARATION BY THE CANDIDATE

I hereby declare that this dissertation entitled “Efficacy of a Unani formulation

in Nazla Haar” is a bonafide and genuine research work carried out by me under

the guidance of Dr. Mohd. Aleemuddin Quamri, Lecturer, Department of

Moalajat, National Institute of Unani Medicine, Bangalore.

Date:

Place: Bangalore A.H. Ayshah Fazeenah

iii

National Institute of Unani Medicine (Dept. of AYUSH, Ministry of Health & Family Welfare, Govt. of India)

Kottigepalya, Magadi Main Road, Bangalore-91 Telephone: 080-23584260, Ext: 262, Telefax: 080-23580725

CERTIFICATE BY THE GUIDE

This is to certify that the dissertation entitled “Efficacy of a Unani formulation in

Nazla Haar” is a bonafide research work done by A.H. Ayshah Fazeenah in

partial fulfillment of the requirement for the degree of Mahire Tib (MD Unani) in

Moalajat under my supervision and guidance.

Dr. Mohd. Aleemuddin Quamri Lecturer

Department of Moalajat National Institute of Unani Medicine

Bangalore

Date:

Place: Bangalore

iv

National Institute of Unani Medicine (Dept. of AYUSH, Ministry of Health & Family Welfare, Govt. of India)

Kottigepalya, Magadi Main Road, Bangalore-91 Telephone: 080-23584260, Ext: 262, Telefax: 080-23580725

ENDORSEMENT BY THE HOD AND HEAD OF THE INSTITUTION

This is to certify that the dissertation entitled “Efficacy of a Unani formulation in

Nazla Haar” is a bonafide research work done by A . H . Ayshah Fazeenah under

the guidance of Dr. Mohd. Aleemuddin Quamri, Lecturer, Department of

Moalajat, National Institute of Unani Medicine, Bangalore.

Prof. Mansoor Ahmad Siddiqui Prof. M. A. Jafri Head of the Department Director Dept. of Moalajat National Institute of Unani Medicine National Institute of Unani Medicine Bangalore Bangalore

Date: Date:

Place: Bangalore Place: Bangalore

v

COPYRIGHT

Declaration by the Candidate I hereby declare that the Rajiv Gandhi University of Health Sciences,

Karnataka shall have the right to preserve, use and disseminate this dissertation /

thesis in print or electronic format for academic / research purpose.

Date: Place: Bangalore A.H. Ayshah Fazeenah

©Rajiv Gandhi University of Health Sciences, Karnataka

Dedicated to My Parents

and My Husband

for their

Never-ending Blessings, Love and

Encouragement

Acknowledgment

vi

ACKNOWLEDGEMENT

In the name of Allah, the most beneficent, merciful, omnipresent, omnipotent, anywhere and His

countless peace be upon His prophet and our prince of all living creature, head of Apostles, the

Load Muhammad, his family and his pious.

The completion of this dissertation is not only fulfillment of my dreams but also of my husband,

parents and mother-in-law who have sacrificed a lot for me in completion of this course. The

writing of a dissertation is obviously not possible without the support and company of

numerous people. It is a pleasant aspect that I have now the opportunity to express my gratitude

for all of them.

In the first place, I would like to express my gratitude to Indian High Commission and External

Resource Department, Sri Lanka for select me as a Government nominee for the AYUSH

Scholarship program. I oblige to thank Department of AYUSH, Ministry of Health and Family

Welfare, India and Indian Council for Cultural Relations (ICCR) New Delhi, for considered me as

a foreign nominee, providing me an opportunity for admission in MD course in NIUM, and

continuous financial support during the study.

It gives me immense pleasure to express my eternal and deep sense of gratitude and sincere

respect to my beloved teacher, guide and mentor Dr Mohd. Aleemuddin Quamri, Lecturer Dept.

of Moalajat, NIUM- Bangalore, without whose precious guidance, energetic suggestion,

constructive criticism, extra efforts, immense help, supervision and encouragement at each and

every point of this study, it would not have been possible for me to carry out this work. I

acknowledge his intelligent, diligent and serious help in transforming this would be fantastic

ideas into comprehensive and logical statements which are in front of you as a dissertation.

I wish to express my deep sense of gratitude to Prof. M. A. Jaffri, Director National Institute

of Unani Medicine (NIUM), Bangalore for moral encouragement and providing the necessary

facilities for research as and when sought for.

It is my duty to thanks to Prof. Kshanika Hirimburigama, Vice Chancellor, University of

Colombo and Dr. Jayasinghe, Director, Institute of Indigenous Medicine (IIM), Rajagiriya, Sri

Lanka giving me an opportunity to complete my PG study.

I express my sincere thanks to Prof. M A Siddiqui, HOD Moalajat NIUM Bangalore, for his

valuable suggestion, constant encouragement and cordial cooperation as and when sought for.

Acknowledgment

vii

I wish to express my cordial and humble thanks to beloved teachers o f IIM, University of

Colombo, Sri Lanka for their continuous encouragement, constant help and affectionate attitude

during the entire course of my study.

I take this opportunity to express my heartfelt reverence and highly obliged to my respected

teachers Prof. Dr. Mohd Anwar, HOD of Dept. of Ilaj Bil Tadbeer, Dr. Tanzil Ahmad, Reader,

Department of Moalajat, Dr. Abdul Nasir Ansari , Reader, Department of Ilaj Bil Tadbeer and

Dr. G. Sofi, lecturer, Dept. of Ilmul Advia, NIUM, for their kind support, guidance and

valuable suggestions.

I have much pleasure in expressing my grateful thanks to my colleagues Dr. Rumaiza, Dr.

Nasmeer, Dr. Musta Ali, Dr. Abdur Rasheed, Dr. Mohamed Ali, Dr. Razaur Rasheed, Dr.

Nadeem Ahmad, Dr. Abdal Ahamed, Dr. Qutubuddin, Dr. Sadique Ali, Dr. Nafees Iqbal, and

Dr. Aliya, whose advice has been great help to me. I sincerely appreciate their cooperation and

support.

I also express my thanks to my seniors Dr Raeesuddeen, Dr. Nusrat, and Dr. Azad as well as

juniors Dr. Humyra, Dr. Aslam, Dr. Sheeraz, Dr.Imtiyaz, Dr.Naseemul Hasan,

Dr.Sarfaraz, Dr. Yasir, Dr. Arshadwani, Dr. Ghuffran and Dr. Zahir who helped me to

complete this dissertation. I wish to thank from the core of my heart to all my batch mates from

the Depts. of Qabala, Hifzane Sehat, Ilmul Advia, and Ilmul Saidla.

I would like to express my sincere thanks to Dr. Renuka BN, Pathologist Hospital Laboratory,

NIUM for her kind support, advice and showing practical interest in my laboratory

work. I owe my sincere thanks to Mrs. Sanjeeda Tabassum (Biochemist), Mohd Haneef, Mohd

Zaki, Mrs. Kavitha , Rohit, and Govardan for helping me in my laboratory work. I

would like to thank Dr. Mahboob Pasha Consultant Radiologist and Mohd. Sameer for their

valuable co-operation during the trial. I also express my thanks to Dr. Nafees Khan, Chief

Pharmacist; Mr. Fazil and Mr. Kashif (NIUM pharmacy staff) for providing best quality drugs.

I express my intense sense of thanks to library staff (NIUM) Mr. Ehtisham. Mr. Danish and Mr.

Mudassir who never expressed signs of exhaustion in providing me literature. I am thankful to

Mr. Syed Tarique for his co-operation in my study.

It is my obligation to express my heartfelt gratitude to one of my paternal uncles M.S.M Razik,

design director at international capital trading for his moral, sound and stable support in each

and every step of my progress.

Acknowledgment

viii

This dissertation would never have been completed without love, moral support, patience,

devotion, compassion, generosity, encouragement, affection and sacrifice from my beloved

siblings and in-laws. I am greatly indebted to them.

Lastly I express my appreciation to all the patients, without whose co-operation, this

study would not be possible.

It is not possible to acknowledge individually all of my friends and colleagues who helped me

in various ways and in different aspects of the study, nevertheless, I am grateful to all of them

and at the same time I express my apology for all those whom I could not mention by their names.

I pray to Almighty Allah to show me the right path, the path of those whom He has

bestowed His Grace, those whose (portion) is not wrath, and who go not astray (Aameen).

Date: Fazeenah Hameed

Place: Bangalore

ix

LIST OF ABBREVIATIONS AND SYMBOLS USED

AD Anno Domain

AMP Adenine Mono Phosphate

AR Allergic Rhinitis

ARIA Allergic Rhinitis and its Impact on Asthma

AT After Treatment

Bal. Balghami

BC Before Christ

BT Before Treatment

β Beta

Chr. Christian

cm2 Centimeter squared

CRF Case Report Form

Dam. Damavi

DLC Differential Leukocyte Count

du. Dust

ed. Edition

e.g. Example

ESR Erythrocyte Sedimentation Rate

et al et alii or et alia (and other)

etc. etcetera (and the rest)

GCP Good Clinical Practice

gm Gram

GMP Good Manufacturing Practice

Hb Hemoglobin

HCl Hydrogen Chloride

x

hr. Hour

ICR International Consensus Report

i.e. “idest” (that is)

IgE Immunoglobulin E

IPD In Patient Department

L Liter

LFT liver Function test

ml milliliter

m meter

n total number

NARES Non Allergic Rhinitis with Eosinophilia Syndrome

NIUM National Institute of Unani Medicine

NSFE Nasal Smear For Eosinophils

OME Otitis Media with Effusion

OPD Out Patient Department

P Probability of error

PAR Perennial Allergic Rhinitis

PND Post Nasal Drip

PNS Para Nasal Sinuses

RAST Radioallergosorbent Test

RBS Random Blood Sugar

RFT Renal Function Test

S. Serum

SAR Seasonal Allergic Rhinitis

SEM Standard Error of Mean

SES Socio Economic Status

SGOT Serum Glutamic Oxaloacetic Transaminase

xi

SGPT Serum Glutamic Pyruvate Transaminase

T Lymph. Thymus Lymphocytes

TLC Total Leukocyte Count

TSSS Total Symptoms Severity Score

U.S. United State

Viz. Videlicet (namely)

Vol. Volume

WHO World Health organization

w .r. t. with respect to

Z Zizyphus

$ Dollar

≥ Greater than or equal

≤ Lesser than or equal

& ampersand = and

< Less than

> Greater than

% Percentage

0C Degree Centigrade

Abstract

xii

Abstract

Background: Nazla Haar is a multifactorial disease represents nasal and ocular symptoms that occur as a result of the development of an inflammatory hypersensitivity reaction in the nasal mucosa, with the common result being a sensation of excess mucous, sneezing and or nasal congestion, which is quite similar to that of rhinitis of absolute allergic origin. Its worldwide prevalence varies from 2% to 20%, nearly 80 million people experience 7 or more days of nasal or ocular symptoms in each year, as one of the commonest allergic disease, it affects more than 50% of atopies in India. Mostly disease onset is seen in 12- 16 years of age or 80% before the age of 20 with symptoms relatively uncommon over the age of 50 years. Despite the use of numerous newer therapeutic regimens it has remained confront because of relapse, recurrence and resistance. The holistic approach of Unani treatment will have a thriving management in diseases with temperamental affiliation and its evidences were found throughout the history that Unani medicine has proven efficacy in Nazla Haar, but lacking scientific data for validation. Therefore, a Unani formulation was selected to conduct a clinical study to evaluate safety and efficacy in Nazla Haar.

Method: A randomized single blind placebo controlled study was conducted over 40 patients after obtaining an informed consent by allocating them in to test (n=30) and placebo (n=10) groups. Test group was given decoction of Behidana, Unnab and Sapistan with Sharbate Banafsha, whereas, placebo group received caramel syrup, both groups were received drugs in a dosage of 25 ml twice a day for 15 days. The efficacy of the study was observed subjective and objectively in three follow ups, on four point scale Total Symptom Sever ity Score, the overall response was assessed by using statistical tests like Paired, Friedman, Fisher’s Exact and Kruskal- Wallis with Dunn’s Multiple Comparison.

Results: Test drug was found to be effective with P<0.01 in comparison with placebo.

Interpretation and conclusion: The study revealed that the test drug is effective in reducing the symptoms of Nazla Haar, without any adverse effects. Therefore, it is concluded that the test drugs can be used therapeutically.

Key words: Nazla Haar; rhinitis; Unani formulation; placebo; TSSS.

xiii

LIST OF CONTENTS

S. No. Topic Page No.

1. Introduction 1-6

2. Aims & Objectives 7

3. Review of literature 8- 58

4. Materials and Methods 59- 66

5. Results and Observations 67- 93

6. Discussion 94- 106

7. Conclusion 107- 108

8. Summary 109- 114

9. Bibliography 115- 126

10. Annexure 127-138

xiv

LIST OF TABLES

S. NO Titles Page No.

1. Distribution of patients according to Age 67

2. Distribution of patients according to Sex 68

3. Distribution of patients according to Marital status 69

4. Distribution of patients according to Religion 70

5. Distribution of patients according to Dietary habit 71

6. Distribution of patients according to Socio Economic Status 72

7. Distribution of patients according to Mizaj 73

8. Distribution of patients according to Family History 74

9. Distribution of patients according to Occupation 75

10. Distribution of patients according to Duration of illness 76

11. Distribution of patients according to Treatment history 77

12. Distribution of patients according to Seasonal variation 78

13. Distribution of patients according to Effect of Allergens 79

14. Effect of drugs on Rhinorrhoea 80

15. Effect of drugs on Sneezing 81

16. Effect of drugs on Nasal Congestion 82

17. Effect of drugs on Itchy Nose 83

18. Effect of drugs on Itchy Mouth or Throat 84

19. Effect of drugs on Lacrimation 85

20. Effect of drugs on PND 86

21. Effect of drugs on Headache 87

22. Effect of drugs on NSFE 88

23. Effect of Study on Objective cum Safety Parameters 89

24. Effect of drugs on TSSS 90

25. Overall Effect on the study based on TSSS and NSFE 91

26. Overall Effect on the study in terms of Response 92

27. Baseline characteristics of the research sample 93

xv

LIST OF GRAPHS

S. NO Titles Page No.

1. Distribution of patients according to Age 67

2. Distribution of patients according to Sex 68

3. Distribution of patients according to Marital status 69

4. Distribution of patients according to Religion 70

5. Distribution of patients according to Dietary habit 71

6. Distribution of patients according to Socio Economic Status 72

7. Distribution of patients according to Mizaj 73

8. Distribution of patients according to Family History 74

9. Distribution of patients according to Occupation 75

10. Distribution of patients according to Duration of illness 76

11. Distribution of patients according to Treatment history 77

12. Distribution of patients according to Seasonal variation 78

13. Distribution of patients according to Effect of Allergens 79

14. Effect of drugs on Rhinorrhoea 80

15. Effect of drugs on Sneezing 81

16. Effect of drugs on Nasal Congestion 82

17. Effect of drugs on Itchy Nose 83

18. Effect of drugs on Itchy Mouth or Throat 84

19. Effect of drugs on Lacrimation 85

20. Effect of drugs on PND 86

21. Effect of drugs on Headache 87

22. Effect of drugs on NSFE 88

23. Effect of drugs on TSSS 90

24. Overall effect on study in terms of Response 92

INTRODUCTION

Introduction

1

INTRODUCTION

Nazla is derived from the term Nuzool which means “to descend”, literally stands for

dripping down, and the same is being used synonymously for Zukam. In fact, it is the

falling of matter from the brain and its cavities either towards throat or nose, the

earlier is termed as Nazla and the later one is Zukam, both conditions exhibit similar

pathogenesis.

The nose is the superior part of the respiratory tract; its primary function is

humidification, filtration and olfaction, with a clean and refresh nasal mucous blanket

serving to trap particulate matter. Human beings normally produce about two liters of

mucus per day from their nasal lining. Its function and / dysfunction has been an issue

of concern to physicians throughout the ages. Moreover, upper respiratory diseases

are well known since Greco-Arabic period. Ibn Abbas Al Majoosi rightly described

Nazla under the heading of the disease of nose. Usually patients with nasal disorders

may present with a variety of chief complaints such as nasal symptoms rhinorrhea,

sneezing and congestion which may be due to allergic, infectious, inflammatory, or

structural causes. When normal nasal mucosal function is lost due to inflammation, it

leads to nasal crusting or obstruction, hypersecretion or postnasal drip, coughing,

facial pressure, and fatigue.

In Nazla the predominant symptoms are rhinorrhea, sneezing, nasal congestion and

itchy nose. Based on the nature of matter involved it is of two types i.e. Haar and

Barid. Nazla Haar is a state in which the matter descends from the brain towards

throat, which is very thin, watery like in consistency and irritative in nature, resulting

in the manifestation of rhinorrhea, nasal congestion, sneezing, redness of the face,

lacrimation, burning or itchy nose, eyes, heaviness of the head and malaise.

Introduction

2

Nazla Haar is a multifactorial disease manifested by nasal and ocular symptoms that

occur as a result of the development of an inflammatory hypersensitivity reaction to

either extrinsic or intrinsic or both factors. In fact it is a type of inflammatory process

of the nose, with the common result being a sensation of excess mucous and / or nasal

congestion. This state of disease is quite similar to that of rhinitis of absolute allergic

origin, in which the patient may perceive nasal drainage (fluid dripping from the nose)

either anteriorly or posteriorly, and the symptoms may last for a short duration and

sometimes persist despite treatment.

The most common ageing symptom of the disease onset is 12- 16 years or 80% before

the age of 20, with symptoms relatively uncommon over the age of 50 years. Usually

symptoms are often paroxysmal sneezing, rhinorrhea with clear watery irritative

secretions, nasal congestion and itching in the nares and palate. The effect of rhinitis

can be as severe as conditions such as asthma and diabetes. The patient may be able to

associate his or her symptoms with a particular season, location, activity or other

triggerers that gives insight into the type of offending factor. Epidemiological studies

have consistently shown that asthma and rhinitis often coexist in the same patients.

The prevalence of asthma varies from 10% to 40% in patients with rhinitis. One study

has shown that allergic rhinitis usually precedes asthma and can be considered as risk

factor for the development of asthma. Symptoms may improve with advancing age,

but the disease is chronic in nature and complete remission is uncommon,

emphasizing the importance of considering the disorder at all stages of life.

Nazla Haar is the most common and main reason that a patient seeks the advice of a

physician at primary care. Over 20 million visits by patients per year in US alone are

devoted to this complaint. Each year nearly 80 million people experience 7 or more

Introduction

3

days of nasal or ocular symptoms as the commonest allergic disease affecting more

than 50% of atopies in India. Its worldwide prevalence rate varies from 2% to 20%.

Recently, World Health Organization has estimated that 400 million people in the

world suffer from allergic rhinitis. Incidence rates in Asia-Pacific are estimated to be

as high as 48% and rising as societies become more urbanized and adopt western

lifestyles.

The prevalence of the disease as a result of respiratory allergy is constantly increasing

and is recognized as a major public health burden that causes major illness and

disability worldwide. Its disabling effect is found on all individuals irrespective of age

and ethnic background. Approximately 20 billion dollars are spent globally each year

in relation to its costs for medications, lost productivity and physician consultations,

under diagnosis, lack of treatment and non compliance are added in the economic

burden is significant and even heavier in societies with emerging incomes. High

consumption of health resources was observed in the ‘Allergies in Asia-Pacific’

survey, which revealed that children visited a physician on an average four times in a

year. When the cost of treating comorbidities such asthma is considered, the annual

per patient direct costs in Asian countries can be as high as $ 1,010 U.S. dollars per

person.

Though the disease is not a life threatening, but its impact as risk factors include a

combination of environmental and genetic interactions reflects the involvement of

nasal, ocular and constitutional symptoms with a variety of comorbid conditions,

including asthma, chronic sinusitis, nasal polyposis, secretory otitis media, and sleep

disorders which lead to open mouth breathing, sore throat and snoring. In addition to

daytime fatigue and somnolence, nocturnal sleep impairment is also associated with

Introduction

4

depression, irritability, memory defects, inability to concentrate and listless, decrease

alertness and overall reduced quality of life.

There is no standard set of criterion for the diagnosis of rhinitis based on nasal

symptoms alone. In most studies, the criteria for diagnosis are based on the subject’s

reporting or as a complex genetic disorder, in certain cases, patients give a positive

family history otherwise diagnosis is primarily based on the clinical symptoms and

exposure history. Physical examination reveals the changes in the nasal mucosa; in

children a transverse nasal crease, a high arched palate, mouth breathing and dental

malocclusion are often observed. Nasal smears (Hansel stains) of nasal secretions are

often required, which typically reveal eosinophils. The diagnosis is confirmed by

demonstration of specific IgE antibodies reactive to the relevant pollen through either

positive allergy skin tests or IgE immunoassays. Identification of specific triggering

allergens is essential for recommending appropriate environmental controls specific to

the causative allergen.

Medical management as offered by alternative or primary choice of treatment by the

people consists of the use of systemic antihistamines (Cetrizine HCl, Loratadine,

Diphenhydramine HCl, and Promethazine HCl etc.), decongestants (Ephedrine,

Phenylephrine, Oxymethazoline) and topical corticosteroids (Glucocorticosteroids,

Hydrocortisone) do not get cure for all patients, often necessitating immunotherapy

too. Due to the side effects associated with these drugs such as local nasal irritation

and burning, crusting, epistaxis, nasal septal perforation, pharyngeal candidiasis; and

high recurrence rates with limited success; moreover, first generation antihistamines

cross the blood brain barrier and have significant sedative and anticholinergic effects

that will interfere the activities of school, work, driving, or use of machinery,

Introduction

5

whereas, 10-15% of treated patients complained of sedation, virtually all subjects

demonstrate decreased motor skills, diminished driving ability and reduced cognition.

Despite the use of numerous newer therapeutic regimens, rhinitis has remained as

enigma because of relapse, recurrence and resistance. There is a dire need to develop

a safe and efficacious therapy from the treasures of Unani system of medicine which

offers a variety of effective and safe treatment modes for such disease. Because,

Unani system of medicine considered Nazla Haar is a disease with multiple

etiologies, accordingly it was treated with holistic approach by adopting the principles

of contrary to the disease state. In this context some common single drugs used such

as Banfsha, Behidana, Unnab, Sapistan, Asalussoos, Aalubukhara sheerin,

Turanjabeen, Tukhme khitmi muqashar, Kishneez khushk, Barg wa gule aazad, Gulab

sufaid, Anjeer siya, Maghze khiyar shamber, Sheere tukhme kahu muqashar, Sheere

maghze kaddu, and Maghze badam. Similarly certain compound drugs used are

Sharbate banfsha, Laooqe khashkhash, Luabe behidana, Sharbate unnab, Khameere

gauzaban, Triyaqe nazla and Sharbate fardyaris etc.

Based on the range of prescriptions comprises on single and compound formulations

mentioned by the Unani physicians for the management of Nazla Haar, a formulation

from Byaze Kabir is selected which consists of Behidana, Unnab and Sapistan in the

form of Joshanda along with Sharbate Banafsha may prove to be effective in the

management of Nazla Haar.

Therefore, the present study entitled “Efficacy of a Unani formulation in Nazla

Haar” was conducted at National Institute of Unani Medicine Hospital, Bangalore

over a period of 09 months from March 2011 to December 2011. A total of 55

patients were registered for screening out of which 15 patients did not fulfill the

Introduction

6

inclusion criteria, therefore, excluded, and remaining 40 patients were randomly

allocated to two groups viz, 30 in test and 10 in placebo. Test group was given

decoction of a Unani formulation along with Sharbate Banafsha 25ml orally twice a

day for 15 days and the placebo control group was treated by caramel syrup with the

same quantity and duration. The efficacy of the study was observed in both groups in

three follow ups i.e., 4th, 8th and 15th day, based on the severity of disease and the

effect of t he treatment on TSSS (Total Symptom Severity Score) a four point

arbitrary grading scale (0- absent; 1- mild; 2- moderate; 3- severe).

The pre and post treatment data from both groups were compared, test group has

shown very significant reduction (p<0.01) in the severity of subjective parameters like

rhinorrhoea, sneezing, nasal congestion, itchy nose, mouth or throat, lacrimation, post

nasal drip and headache, while placebo control group remained insignificant. The

objective parameters especially, NSFE was observed and analyzed in both groups the

test group after treatment effects exhibited highly significant (p<0.001) in

comparison of baseline before treatment, whereas, placebo control group has shown

no significant changes.

Moreover, this study has shown no clinically significant adverse effects, and overall

compliance to the treatment was commendable. On the basis of results and

observations, it can be concluded that the test drug is effective and safe as a treatment

for Nazla Haar.

OBJECTIVES

Objectives

7

OBJECTIVES OF THE STUDY

To evaluate safety and efficacy of a Unani formulation in Nazla Haar.

To validate the Unani concept of Nazla Haar with Rhinitis.

REVIEW

OF

LITERATURE

Review of Literature

8

HISTORICAL BACK GROUND OF NAZLA HAAR

‘Nazla Haar’ has been described as a disease in detail with signs and symptoms along

with treatment in various Unani texts under the chapter of ‘Nazla wa Zukam’.

According to Unani physicians, Nazla is a condition with watery irritating nasal

discharge dripping down towards the throat, if the same flow towards the nose, then it

is termed as Zukam.1

Nazla wa Zukam as disease with complex aetiology and difference of opinion in its

types was found throughout the period of ancient and medieval Unani practitioners,

but the predominant symptoms of Nazla resembling at par with the existing medical

condition rhinitis.

Probably, Hippocrates (460- 377 BC) was the first person who defined Nazla wa

Zukam along with its etiology, types and management.2

Galen (131-201 AD) defined different types of Nazla specifically Nazla Haar and its

complications with treatment.2

Rabban al Tabri (810- 895 AD) mentioned in detail about the types, causes and

treatment of Zukam besides considering Nazla as synonym.3

Mohamed Bin Zakaria al Razi (850-923 AD) described the aetiopathogenesis and

management of Nazla Haar.2

Hakeem Abul Mansoorul Hassan al Quamri (9th century AD) described Nazla as a

state in which fazil rutubate dimaghiya discharges from the ventricles of the brain

dribbled towards the palate, whereas, Zukam as a state where the same secretion

discharges through nostrils. He has also explained the differences between Nazla wa


9

Zukam, as litting down of the fazil rutubate dimaghiya towards lungs and thoracic

region is Nazla. Furthermore, he classified Nazla wa Zukam into two types as Haar

and Barid.2

Ibn Abbas al Majoosi (930-999AD) has described in detail about the Nazla wa

Zukam as diseases under the heading of disease of nose, he has added that both

Warme Haar and Barid can affect the mucous membrane of the nose. 4

Ibn Sina (980-1037 A.D) in “Al Qanoon Fit Tibb” an encyclopedia of medicine,

served as a standard text book of medicine in Europe till 17th century A.D. described

extensively the etiopathogenesis, types, clinical presentation and treatment of Nazla

wa Zukam including Nazla Haar.5

Abul Hassan Ahmed Bin Mohd Tabri (10th century AD) applied the term Zukam to

all forms of Nazla wa Zukam.6

Ibn Zohar (11th century AD) an author of “Kitabul Taisir’ has quoted the term Nazla

and its treatment.7

Ibn Rushd (12th century AD) stated that Nazla is a condition in which rutubat falls

from the head and that can cause cough with bronchospasm.8

Abu al Hassan Ahmad Bin Jurjani (12th century AD) mentioned Nazla as a

condition where there is watery irritating nasal discharge (mad’dae raqeeqa) dripping

down towards the throat, if the same mad’da flows towards the nose with sense of

burning (sozish) is considered as Zukam.1

Allama Nafees Bin Auz Kirmani (15th century) associated certain terms with Nazla

wa Zukam, such as Coryza and Catarrh, where Nazla means ‘to descend’, Coryza for

‘nasal congestion’ and Catarrh for ‘running nose’.9


10

Hakeem Mohd Akbar Arzani (17th century AD) explained the difference between

Nazla and Zukam similar to that of above mentioned Atibba.10

Azam Khan (1813 AD) and Allama Hakeem Mohd Kabeeruddin (1889- 1977 AD)

have considered Nazla wa Zukam as a common term, and described as the infiltration

of wastes from the brain, and origin of the causative substance (mad’da) is same in

both the conditions i.e. falling of mad’da from the brain.19, 11

The symptoms of Nazla Haar resembles with the symptoms of rhinitis, which occurs

mostly due to allergy. Allergic diseases such as asthma, urticaria and eczema

including rhinitis have been known for centuries, and their history dates back to

antiquity.13

In the modern medical literature nasal allergies were known as hay fever, and today

hay fever is the common name for allergic rhinitis, 14 especially for seasonal allergic

rhinitis.13, 15, 16

Seasonal allergic rhinitis was first described in the United States in 1872 (autumnal

catarrh or ragweed hay fever) and in England in 1873 (catarrhus aestivus). The

disease was well recognized in England and Germany by 1900 and in the United

States by 1920.17

Rhinitis is the inflammation of the nasal mucosa, usually due to allergic origin. The

term ‘allergy’ first appeared in the medical literature in 1906.13

In 1911, Sir Henry Dale identified the role of histamine in an allergic reaction, 13 and

the first paper on immunotherapy against pollen “toxin” was published in the same

period. At that time, hay fever was considered to be a disease of the affluent and was

rarely reported among working class people, especially farmers.17


11

In 1929, the definition of allergic rhinitis was formulated by Hansel.18

In 1930s, allergic rhinitis became sufficiently common to allow the development of

the subspecialty of allergy.17

In 1935, the University of Virginia appointed a professor of Allergy as an established

area of concern in medicine.17


12

DEFINITIONS

Nazla Haar is a condition with watery irritating nasal discharge dripping down

towards throat, 1 with sense of burning (sozish) in nose, face and eyes with

lacrimation, and also alters the sense of olfaction.5

Rhinitis is generally defined as an inflammatory process in the nose, which commonly

results being a sensation of excess mucous or nasal congestion. The patient may have

a sensation of fluid dripping from the nose, either coming from the nose anteriorly or

posteriorly.1, 10, 12, 19, 20, 21, 22, 24

Allergic rhinitis is an immunologic response of nasal mucosa to air born allergens18

and is characterized by watery nasal discharge, nasal obstruction, sneezing and itching

in the nose. This may also be associated with symptoms of itching in the eyes, palate

and pharynx.25

The International Consensus Report (ICR) defined rhinitis as, a patient with one or

more of the classical symptoms of nasal obstruction, rhinorrhea, sneezing, or itchy

nose. Further, its algorithm stated that the definition of rhinitis must include at least

any two of the nasal symptoms on most days.26


13

ANATOMY AND PHYSIOLOGY OF NOSE

The nose is the superior part of the respiratory tract and contains the peripheral organ

of smell.27

The nose is divided into two as external nose and nasal cavity.28

The external nose has a skeletal framework particularly partly bony and partly

cartilaginous.

The nasal cavity extends from the external nares or nostrils to the posterior nasal

apertures, and is subdivided into right and left halves by the nasal septum. Each half

has a roof, a floor, and medial and lateral walls.28

The nasal mucosa lines the entire nasal cavities except for the vestibule of the nose. It

is firmly bound to the periosteum and perichondrium of the supporting structures of

the nose. The inferior 2/3 of the nasal mucosa is the respiratory

mucosa (Schneiderian membrane) 30 and air passing over this is warmed and

moistened before it passes into the lungs. The superior 1/3 is the olfactory mucosa.27

The total surface area available in the nasal mucosa is estimated to be about 180 cm2,

of which 10 cm2 is olfactory mucosa and 170 cm2 is the richly vascularized

respiratory mucosa.29

Nasal mucosa and respiratory epithelium:

The lining of the anterior part of the nasal cavity and vestibule is continuous with the

skin, and consists of keratinized stratified squamous epithelium overlying a

connective tissue lamina propria. Posteriorly, at the limen nasi, the mucosa lined at

first by nonkeratinizing stratified squamous epithelium, then by pseudostratified

ciliated (respiratory) epithelium with numerous goblet cells. Respiratory epithelium


14

forms most of the surface of the nasal cavity, and so covers the conchae, meatuses,

floor and roof, except where the olfactory epithelium is present.31

The nasal mucosa has numerous underlying seromucous glands within its lamina

propria, which makes the surface sticky so that particles in the inspired air are

deposited on the surface. It is adherent to the periosteum or perichondrium of the

neighbouring skeletal structures. The mucosa is continuous with the nasopharyngeal

mucosa through the posterior nasal apertures, the conjunctiva through the naso-

lacrimal duct and the lacrimal canaliculi, and the mucosae of the sphenoidal,

ethmoidal, frontal and maxillary sinuses through their opening into the meatuses.31

Here mucous membrane shows variable thickness being thickest over nasal conchae

especially at their ends, quite thick over the nasal septum but very thin in the meatuses

and floor of the nose.25

Nerve supply:

Respiratory nasal mucosa is supplied chiefly by the trigeminal nerve.

The mucous membrane of the nasal septum is supplied chiefly by the nasopalatine

nerve, a branch of the maxillary nerve.

Anterior portion of the septum is supplied by the anterior ethmoidal nerve (a branch

of the nasociliary nerve) which is derived from the ophthalmic nerve.

The lateral walls of the nasal cavity are supplied by branches of the maxillary nerve;

the greater palatine nerve, and the anterior ethmoidal nerve.27


15

Olfactory epithelium:

The peripheral receptors for olfactory sensation are located bilaterally in areas of

sensory epithelium lining the posterodorsal parts of the nasal cavities. This covering

the posterior upper parts of the lateral nasal wall, including the back of the superior

concha, the sphenoethmoidal recess, the upper part of the perpendicular plate the

ethmoid and the roof of the nose arching between the septum and lateral wall,

including the underside of the cribriform plate. The olfactory epithelium is

considerably thicker than the respiratory epithelium.31

Arteries of the Nasal Mucosa

Mucosa of the nasal septum is derived from the maxillary artery (mainly) and greater

palatine artery.

Nasal mucosa supplied by the sphenopalatine artery which is a branch of the

maxillary artery, anterosuperior part of the mucosa of the lateral wall of the nasal

cavity and nasal septum supplied by anterior and posterior ethmoidal arteries,

branches of the ophthalmic artery.

Veins of the Nasal Mucosa

The veins of the nasal mucosa form a venous network of plexus in the connective

tissue of the nasal mucosa. Some of the veins open into the sphenopalatine vein and

drain to the pterygoid plexus. Others join the facial and infraorbital veins. Some

empty into the ophthalmic veins and drain into the cavernous sinus.31


16

LITERATURE REVIEW

Nazla wa Zukam were used synonymously by most of the Unani physicians, but some

of them have difference of opinion, however, in both ailments, the mad’da drips from

the brain.1, 2, 5 The mawad of Nazla is sometimes temperamentally hot and thin in

consistency, or cold and viscous.1

Ibn Sina in “Al Qanoon Fit Tibb”, considered Nazla wa Zukam as two separate

disease entities. Nazla Haar is one of the types of Nazla, accordingly described

extensively about its etiopathogenesis, clinical presentation and treatment. 2, 5, 7, 19, 20

According to him both Nazla wa Zukam exhibit the complex state, i.e. falling of

mad’da from the brain.1, 5

Nazla wa Zukam have been considered as a common term to describe the ‘infiltration

of dimaghi fuzlat’ in the most of Unani texts, because in both conditions the mad’da

comes from the dimagh and move towards either nose or throat.5, 12, 19

Differentiating Nazla and Zukam by Buqrat, he defined Zukam is Nazla of nasal

mucosal lining, and the Nazla is a condition in which the nasal mucosa gets inflamed

and always associated with excessive nasal discharge.4, 32

According to Galen there are different types of Nazla, he has specifically defined

Nazla Haar and its complications with treatment. Further, he has clearly mentioned

the importance of hammam in Nazla Haar before the administration of munzij drugs.2

Mohamed Bin Zakaria al Razi has suggested and recommended treatment for various

types and origin of Nazla.2

According to Hakeem Abul Mansoorul Hassan al Quamri Nazla is a condition in

which fazil rutubate dimaghiya discharges from the ventricles of the brain towards the


17

palate, whereas, in Zukam the same secretion dribbled towards the nostrils. He also

explained the marginal differences between Nazla wa Zukam; 5 as litting down of the

fazil rutubate dimaghiya towards lung and thoracic region as Nazla.11, 12 Furthermore,

he classified Nazla wa Zukam into two types as Haar and Barid.2, 5

According to Abul Hassan Ahmed Bin Mohd Tabri, the term Zukam as it is applicable

to all its types. According to him it is an accumulation (ihteqaq) of vapours

(bukharat) in the ventricles of the brain that started dissolving from the cavities of the

head. It supposes that the stagnant matter comes out after dissolutions of it in the form

of liquid, water or vapour through the nostrils, eyes and ears.6

Ibn Rushd has considered the Nazla is one of the causes for cough with

bronchospasm.8 According to Ahmad Hassan Jurjani Nazla is a condition where there

is watery irritating (mad’dae raqeeqa) nasal discharge dripping down towards the

throat, if the same mad’da flows towards the nose with sense of burning (sozish) is

considered as Zukam. Further, he has explained the quality and quantity of the

mawade Nazla, which involve in Nazla Haar.1, 10, 12, 19

Allama Nafees Bin Auz Kirmani has described literal meanings and definitions of the

terms; Zukam, Coryza and Catarrh. Nazla means to descend, Coryza for nasal

congestion and catarrh for running nose, all these conditions are manifested as a

results of inflammation of the nasal mucous membrane.9

According to Abul Hassan Ali Ibn Hubal Baghdadi, Nazla is a condition in which

falling of concentrated (teiz) substance from the dhimagh towards the throat and

chest.20


18

It is well understood that the predominant symptoms of Nazla Haar (rhinitis) are

watery nasal discharge, irritative, nasal block (congestion), redness of the eyes,

cheeks and face, burning sensation of nose, lacrimation, postnasal drip and headache.

This state of disease is quite similar to that of rhinitis of absolute allergic origin. It is

also considered as a systemic illness may be associated with constitutional symptoms

such as fatigue, malaise and headache, 33 as well as it refers to the nasal and ocular

symptoms that occur as a result of an inflammatory hypersensitivity reaction to

aeroallergens deposited on the nasal mucosa and conjunctiva.24


19

EPIDEMIOLOGY

Respiratory allergy (allergic rhinitis and asthma) is a high prevalence disease that

affects an average of 10-15% of the general population. Thus, allergic asthma and

rhinitis are probably the most common immune mediated disorders. The prevalence of

respiratory allergy, especially rhinitis is constantly increasing.34

Nazla Haar (rhinitis) is the most common and main reason that a patient seeks the

advice of a physician at primary care. Over 20 million visits by patients per year in

US alone are devoted to this complaint. Each year nearly 80 million people

experience 7 or more days of nasal or ocular symptoms as 24 the commonest allergic

disease affecting more than 50% of atopies in India.35 Its worldwide prevalence rate

varies from 2% to 20% and the maximum prevalence is observed in the second

decade of life.36 Recently, World Health Organization has estimated that 400 million

people in the world suffer from allergic rhinitis, which is a risk factor for asthma, and

is associated with other allergic diseases such as atopic dermatitis, conjunctivitis,

sinusitis, and nasal polyposis, which requires concomitant treatment 37. Incidence rates

in Asia-Pacific are estimated to be as high as 48% and rising as societies become

more urbanized and adopt western lifestyles.38

The prevalence of the disease as a result of respiratory allergy is constantly

increasing and is recognized as a major public health burden39 that causes major

illness and disability worldwide.41 Its disabling effect is found on all individuals

irrespective of age and ethnic background. Approximately 20 billion dollars are spent

globally each year in relation to its costs for medications, lost productivity and

physician consultations, under diagnosis, lack of treatment and non compliance are

added in the economic burden is significant and even heavier in societies with


20

emerging incomes. High consumption of health resources was observed in the

‘Allergies in Asia-Pacific’ survey, which revealed that children visited a physician on

an average four times in a year. When the cost of treating comorbidities such as

asthma is considered the annual per patient direct costs in Asian countries can be as

high as $ 1,010 U.S. dollars per person.38

Epidemiological studies have consistently shown that asthma and rhinitis often

coexist in the same patients. The prevalence of asthma is less than 2% in subjects

without rhinitis while it varies from 10% to 40% in patients with rhinitis. 41 At the

same time one study has shown that allergic rhinitis usually precedes asthma and can

be considered as risk factor for the development of asthma 18, 41 Nazla Haar exists in

up to 80% of asthma patients and frequently exacerbates asthma and increases the risk

of asthma attacks.18 Chronic rhinitis occurring episodically or continuously is often as

a result of allergic hypersensitivity, though other causes may underlie this

syndrome.42

According to Allergies in Asia-Pacific survey, allergic rhinitis is one of the most

prevalent chronic diseases in children. A recent study has predicted that by the year

2020 as many as one out of two people up to 14 years of age may be affected. With

this projected prevalence, allergic rhinitis is becoming the most common chronic

disease in the pediatric population.38.


21

AETIOLOGY

According to the doctrine of Unani medicine, any state that hampers the equilibrium

of humours (Akhlat) either qualitatively or quantitatively may cause disease.

Nazla Haar is a multi factorial disease 18 occurs as a result of the involvement of

various factors which affects the individual either intrinsically or extrinsically and

sometimes both.

Some of the aetilogies defined by various Unani practitioners are as:

1. According to Ibn Sina

Usually individuals with hot temperament (intrinsic factors) may likely to

develop Nazla Haar. 19

2. According to Samarqand

There are 8 causes for Nazla, viz, four are of Sue mizaj dimagh and other four

are Akhlate arba. 19

3. Extrinsic factors (Asbabe kharija)

Khariji hararat: hararat mizaj, hararate mizaj khaas, uncovered head,

exposure to sunlight, fire, garam hammam, working in hot environment,

applying pungent odour perfumes or smelling/ snuffing of hot drugs such as

mushk, jundbedastar, zafran, onion etc. massaging the head with hot oils or

usage of warm hair oils, sleeping immediately after food, consumption of hot

things like garlic, onion, mustard etc. , bathing after exercise followed by

improper wrapping, or strenuous psychic or physical activity; and also

exposure to allergen like pollen, cotton fur, feather, dust. 1, 3, 5, 6, 12, 19, 20, 21

4. Intrinsic factors (Asbabe dakhila): hammam, riyazat1, 3, 5, 6, 12, 19, 21


22

5. Mostly both intrinsic and extrinsic factors together will produce Nazla wa

Zukam 1, 19

6. Sue mizaj haar 19

7. Sue mizaj of brain 20

8. Zoafe dimagh 21

9. Imtilae aam wa raas (plethora of body and head) 12, 19

10. Tukhma 19

11. Infealate nafsania 19, 21

12. Seasonal variation 21, 43

13. Predisposing factors: 42, 43

I. Age:

It occurs at all ages, 43 but the maximum prevalence is observed in the

second decade of life. 36

II. Heredity/ genetic predisposition play an important part:

If both parents are allergic, there is a high incidence of the disease

occurring in children. 25 But, one study results show that an adult with a

family history of asthma or rhinitis has a risk of three to four fold for

developing asthma and of two to six folds for developing rhinitis over

adults without a family history. 44

III. Hormonal:

Since the disease often begins at puberty. 43

IV. Occupational triggers 15


23

PATHOPHYSIOLOGY

Allergic airway disease is characterized by local tissue damage and organ dysfunction

arising from an abnormal hypersensivity of nasal mucosa response to normally

harmless and ubiquitous environmental allergens.42

Generally, human beings normally produce about 2 L of mucus per day from their

nasal lining. The primary function of the nose is humidification, filtration and also an

olfaction, with a clean and refresh nasal mucous blanket serving to trap particulate

matter. The nasal and sinus lining consists of a ciliated respiratory epithelium; the

cilia function in a highly organized and orderly fashion under normal circumstances to

transport particulate matter trapped in the mucous blanket in a consistent fashion to

allow the mucus to be swallowed, thereby avoiding deposition. The parasympathetic

nervous system controls both vascular tone and mucus production in the nose.

Inflammatory conditions, such as common cold can cause the nasal and sinus lining to

swell. In a normal state, one side of the nose is relatively decongested and the other

side is relatively congested owing to vascular engorgement. This vascular dilatation

allows humidification and warming of inspired air and can also affect the ability to

discern odors in the process of olfaction.24

According to Unani system of medicine the genesis of Nazla is related with extrinsic

and intrinsic causative factors. One or the other of these causative factors causes sue

mizaj in the mucous membrane of the nose. Thus the mucous membrane gets inflamed

and produces secretions, which may be watery (raqeeq) or viscid (ghaleez), hot

(garam) and irritative (lazae) or cold (barid) and benign, distasteful or tasteless

depends upon the causative factors.45


24

Usually it is believed that the effects of heat either externally or internally will causes

increase warmness in brain that leads to temperamental disturbance within the brain,

therefore, to bring back the normal temperament of the brain, the tabiat try to

neutralize the increased warmness of the brain by absorbing fluid from the body

towards the brain. As a result, an excessive amount of fluid accumulated inside the

brain and its cavities, which properly may not be able to metabolized as a

consequence of this, some amount of fluid still remain inside causing derangement of

the local temperament (sue mizaj dimagh) of the brain. Therefore, the brain tries to

expel the fluid which accumulated in the form of fuzlat by either through nostrils or

throat.

Based on the causes and quality of fluid which expels from the brain, it appears to be

an irritant, watery, salty, thin and viscid etc that may cause local tissue inflammation

of the nasal mucosa leading to dysfunction of nose, in modern sense it is considered

as immune response. The inflammatory response mediated by the immunological

factors generally bound to mast cells and basophils triggers the release of vasoactive,

enzymatic, and chemotactic mediators. 42 As a result, this reaction produces

degranulation of the mast cells with release of several chemical mediators, some of

which already exist in preformed state, while others are synthesized afresh. These

mediators are responsible for symptomatology of allergic disease. Depending on the

tissue involved, there may be vasodilation, mucosal oedema, and infiltration with

eosinophils, excessive secretion from nasal glands or smooth muscle contraction.25

This reaction is typically completed in 2 phases, an early phase and a late phase.46

The early phase occurs within minutes after an allergen exposure and is characterized

by sneezing, pruritus, rhinorrhoea and nasal congestion resulting largely from the


25

interaction of histamine with target tissues of the upper airway by activation of tissue

mast cells sensitized by IgE antibodies. 46 Approximately half of all patients with

rhinitis experience the late phase response, which begins 2-4hours following initial

antigen exposure, reach maximal activity at 6-12 hours, and usually resolve within 12-

24 hours. This phase is typically characterized by congestion about 4 to 12 hours after

exposure that corresponds with the recruitment of many inflammatory cells.25, 46


26

CLASSIFICATION OF NAZLA

Primarily two types of Nazla have been defined throughout the Unani literature based

on the involvement of temperament and matter. 2, 5, 19, 20, 22, 47

1. Nazla haar

2. Nazla barid

Apart from the above, some other types of Nazla are:

3. Aetiological types

3.1. Based on mad’da 22, 47

a. Nazla damavi

b. Nazla safravi

c. Nazla balghami

d. Nazla sawdavi

3.2. Based on factors 6

a. Nazla due to Asbabe kharija (extrinsic factors)

b. Nazla due to Asbabe dakhila (intrinsic factors)

4. Based on duration of illness

a. Nazla haad 5, 22 or acute rhinitis 16, , 25

b. Nazla muzmin 22 or chronic rhinitis 16, , 25


27

5. WHO based ARIA classification 15, 39, 49

WHO’s former classification of rhinitis was:

i. Seasonal allergic rhinitis (SAR):

Symptoms appear in or around a particular season when the pollens of

particular plant, to which the patient is sensitive, are present in the

air.25

ii. Perennial allergic rhinitis (PAR):

Symptoms are present throughout the year.25

Later, this classification has been revised and adopted by the ARIA system, which is

based on the duration of symptoms and the severity of the disease.

5.1. Based on duration of symptoms

a) Intermittent rhinitis:

Symptoms that present four or less days per week or not more than

four consecutive weeks per year.

b) Persistence rhinitis:

Symptoms last for more than four days per week and for more than

four consecutive weeks per year.

5.2. Based on the severity

a) Mild

b) Moderate

c) Severe

6. Traditional classification 25, 33, 40

a. Allergic rhinitis

b. Nonallergic rhinitis


28

CLINICAL FEATURES

Clinical features may vary from individual to individual in terms of severity,

frequency, duration and the nature of aetilogies involved. According to WHO, Nazla

Haar (Rhinitis) must include at least two of the nasal symptoms on most days.26 The

patient may be able to associate his or her symptoms with a particular season,

location, activity, or other trigger that gives insight into the type of offending factor.39

1. Nasal discharge (rhinorrhoea) 2, 5,10, 16, 19, 21, 24, 25, 26, 33, 36, 42, 43, 49, 50, 51, 52, 53

2. Paroxysmal sneezing 16, 21, 24, 26, 33, 36, 37, 42, 43, 49, 50, 51, 52, 53

3. Nasal congestion: 5, 16, 20, 21, 24, 25, 26, 33, 37, 42, 43, 49, 50, 51, 52, 53

4. Redness of face and eyes 1, 5, 19, 20, 21, 47

5. Hyper sensitivity 2

6. Burning, 2, 10, 16 irritation, 16, 43 and itching in the nose, eye and throat 1, 19, 20,

21, 24, 26, 33, 36, 37, 42, 43, 49, 50, 52

7. Lacrimation6, 24, 25, 33, 50

8. Post nasal drip (PND) 24, 25, 37

9. Mild headache 1, 6, 21, 25, 33, 43

10. Hot to touch (malmas) 5, 19

11. Hoarseness of voice 5

12. Excess thirsty 6, 21

13. Fatigue 4, 16, 24, 37, 43, 49

14. Lethargy 4

15. Nabz – Azeem, Saree’, wa Mutawatar 19, 47

16. Qarura- Yellowish 19, 47


29

DIAGNOSIS

There is no standard set of criterion for the diagnosis of Nazla Haar based on nasal

symptoms alone.26, 41 In most of the studies, the criteria for diagnosis are based on the

subject’s reporting. 41 A detail history and physical examination is helpful, and also

gives clues to the possible factors. Nazla Haar is primarily a clinical diagnosis based

on symptoms and exposure history.24

DIFFERENTIAL DIAGNOSIS

The symptoms and signs of Nazla Haar frequently overlap with those of other forms

of Nazla wa Zukam and various anatomic abnormalities of the upper airway such as:

1. Nazla barid:

It occurs mainly due to excess Balgham, which is characterized by thick and

whitish nasal discharge (ghaleez, lesdaar mad’da) mild itching and irritation

in the nose, unilateral or bilateral nasal congestion 20 with facial pain. 21, 22

Also there is nasal speech, heaviness of forehead and nose, impaired sense of

smell and breathing difficulty.1, 5, 19, 20

2. Zukam:

It occurs due Infiltration of fuzlate dhimagh, which usually ghaleez and khaam

(thick and immature substance) 20 from the anterior part of the brain towards

the nose. The causative factors may be sue mizaj haar or barid, 4 and sudda

(obstruction).3 There is weakness or laziness, heaviness in the forehead, mild

headache, nasal congestion with dryness, sneezing, and irritating nasal

discharge on and off, 21 reddish nostrils with pain, lacrimation due to

inflammation (mutawarram), 54 nasal speech and impaired sense of smell.4


30

3. Nonallergic rhinitis syndrome:

A. Vasomotor rhinitis:

It can be the primary cause of nasal congestion, rhinorrhea, 36or less

commonly, sneezing paroxysms 55 and pruritus.33 About one- fifth of patients

who seek medical attention at an allergy or immunology subspecialty clinic

complaining of chronic rhinitis will actually have non-allergic, vasomotor

rhinitis; one-third of patients in whom allergic rhinitis is diagnosed will have a

vasomotor component to the disease. Nonspecific nasal hyperreactivity leads

to symptoms triggered by cold temperature, inhaled irritants, strong odors,

spicy food, and other nonallergic environmental stimuli.55

B. Nonallergic rhinitis without eosinophilia:

It is characterized by perennial nasal symptoms of rhinorrhea and/or

congestion that are unrelated to allergen exposure. Nasal symptoms are often

provoked by sudden changes in the environment, airborne irritants or dietary

factors.56

C. Nonallergic rhinitis with eosinophilia syndrome (NARES):

It is characterized by perennial nasal symptoms (particularly nasal congestion)

with nasal and occasionally blood eosinophilia in the absence of documentable

allergen sensitivity.33, 56

D. Hormonal rhinitis:

It is most often characterized by nasal congestion and is usually secondary to

thyroid disease (hyperthyroid or hyperthyroid), pregnancy or oral

contraceptive use.24, 33, 56


31

E. Drug induced rhinitis:

It is usually present with symptoms of chronic nasal congestion and occurs

following the use of both oral and topical medications. Responsible oral

medications include many antihypertensives (most common of which are bête-

blockers and methyldopa), and non steroidal anti-inflammatories. Use of

topical vasoconstrictors (e.g. oxymetazoline, phenylephrine) for longer than 3

days may result in a state of rebound nasal congestion termed ‘rhinitis

medicamentosa’. Repeated use of intra nasal cocaine and methamphetamines

may also cause rebound congestion and occasionally septal erosion and

perforation.33, 56

F. Food-related rhinitis:

It may occur because of IgE mediated reactions or vagally mediated

mechanism

(gustatory rhinitis).56

4. Infectious rhinosinusitis

a. Acute viral upper respiratory infection:

It presents with symptoms of rhinorrhea, congestion, sneezing, and

constitutional symptoms (fever, myalgia, malaise). Usually, no pruritus and

symptoms resolve within 7 to 10 days.56

b. Acute Bacterial rhinosinusitis:

It most often presents with symptoms of purulent anterior rhinorrhea or post

nasal drip, facial pain or pressure, and persistence or worsening of nasal

congestion. Chronic bacterial sinusitis usually presents with chronic (longer


32

than 8 weeks) symptoms. However, no single symptom or sign is reliable for

distinguishing rhinitis from sinusitis.56

5. Anatomic abnormalities usually present with obstructive symptoms without other

symptoms of rhinitis, such as sneezing, rhinorrhea, or itching.56

a. Septal deviation:

It can be visualized with an otoscope. It is most often asymptomatic; severe

deviation may cause symptoms of unilateral congestion.

b. Adenoidal hypertrophy:

It is typically seen in young children, causes bilateral nasal obstruction, and is

often associated with nocturnal mouth breathing and snoring.

c. Nasal polyps:

These are benign, inflammatory growths that may result in unilateral or

bilateral nasal obstruction, rhinorrhoea, hyposmia and chronic sinusitis.24, 55, 56

d. Intranasal foreign bodies:

Usually occur in young children, often consists of a small plastic toy part.

Foreign bodies usually cause unilateral nasal obstruction with or without

rhinorrhoea.56

6. Systemic diseases involving the upper airway: 56

a. Wegener granulomatosis:

This is a systemic condition which affects the nose, upper respiratory tract,

lungs and kidneys. Rhinorrhoea starts with clear nasal discharge, which

becomes blood stained and purulent.43


33

b. Sjogren syndrome:

It is an autoimmune disease that destroys exocrine glands and impairs mucous

gland function. Occasionally, the nose may be prominently involved, with

symptoms of congestion, dryness and crusting.43

c. Sarcoidosis:

This is a granulomatous systemic disease with nasal obstruction, purulent and

blood stained nasal discharge.43


34

INVESTIGATIONS

The diagnostic tests for Nazla Haar are:

Complete blood picture with Haemogram

Total IgE levels

Nasal smear for eosinophils (NSFE) or Nasal cytology

Skin prick testing

Intradermal testing

Nasal provocation test

Radioallergosorbent test (RAST).35, 39, 57

Procedure of Nasal smears for eosinophils:

Sample of nasal secretion was obtained from either by blowing of the nose or by

gentle scraping of the lateral wall of the nasal cavity. The material was smeared on

glass slides, flooded them by diluted Giemsa stain (1ml Giemsa stain was diluted by 9

ml of distilled water), and kept them for dry. Then, the stained slides were observed

under the electronic microscopy in different powers for eosinophils.


35

COMPLICATIONS ASSOCIATED WITH NAZLA HAAR

When Nazla Haar is untreated or inadequately treated, symptoms may become

chronic and contribute to conditions such as:

Bronchial Asthma (Ribu wa dama) Nazla Haar usually precedes asthma and

considered as a risk factor for the development of asthma. Nazla Haar exists in up to

80% of asthma patients and frequently exacerbates asthma and increases the risk of

asthma attacks.2, 15, 18, 20, 23, 24, 25, 41, 44, 51, 52, 58

Otitis media (Warme gosh): A study has shown that 40-50% of children older than 3

years with chronic otitis media have confirmed allergic rhinitis.19, 59, 65

Serous otitis media: Numerous studies have been performed to determine the

relation between allergy and otitis media with effusion (OME); the incidence of

allergic rhinitis in OME has been found to vary from 14% to 89%. 24, 25, 42, 59, 60

Nasal polyps, 15, 24, 25, 43 Rhinosinusitis, 59 Sinusitis, 15, 24, 25, 42, 65 Respiratory

infections and Orthodontic malformation, 15, 25 Dyspnoea, 20 Pneumonia

(Zaturriya), 1, 5 Pleurisy (Zatuljenb), Tuberculosis (Sil wa diq), 1, 2, 5, 20,

Stomachache (Darde medda), 1, 5, 19 Shosa, 20 Ishaal, 5,19, 20 Qulanj, 2, 5, 19 Falij,

Warme sadar, toothache, conjunctivitis, 19, 52 Migraine, Numbness (Khadar),

Deafness, 19 Fasade hazm, 2 and Khunnaq 1, 2

The day time tiredness experienced by the vast majority of the sufferers experience

disrupted sleep (Insomnia) at night due to nasal obstruction, which leads to open

mouth breathing, sore throat and snoring. 57 In addition to daytime fatigue and

somnolence, 63 nocturnal sleep impairment 14, 15, 18, 24, 57, 63, 65 is also associated with

depression, irritability, memory defects, inability to concentrate, 14, 34, 57, 61, 63 listless


36

and irritable, 14, 61 decrease alertness and overall reduced quality of life. 18, 23, 52, 58, 63, 65

Further, Nazla Haar can alter the self perceived health status, pose limitations in

everyday activities and affect the working and school productivity, 34, 52, 65 and also

have detrimental effects on emotional and social wellbeing.65


37

PREVENTIVE MEASURES

Avoid day time sleep and sleep on back 21 and / or sleep immediately

following meal.19

Devoid warmness of the body

Precaution from oily, Ghaleez lesdaar and delayed digestible foods, meat,

alcohol, onion, garlic, tea, akhrot, pista etc. sour things like milk, curd along

with Ghaleez and saqeel ghiza, 21 but if they feel weakness in the body, they

can use chicks with meats (ratab gosht), curd.19, 47

Reduce the quantity of food and drink 2, 19, 21

Try to avoid exposure to sunlight, hot or cold air and water. 2, 19, 21

Avoid strenuous exercise or physical activities.19

Samaghe suddab and Rai should be applied on the head immediately after

bath.2

The mainstay of treatment of Nazla Haar involves identification of avoidance of

provoking allergens where possible and the use of oral immunomodulatories.

Although the concept of allergen avoidance seems straightforward and obvious, in

practice it is often difficult to undertake. However, it is now possible to document

environmental allergen exposures with a great degree of precision. Allergen

avoidance measures such as: 56, 64.

No excessive use of seasonal fruits and khushboodar snuff (extreme flavors).21

Allergic rhinitis caused by exposure to plant pollens or seasonal molds,

avoidance of outdoor activity during peak pollen hours i.e. late morning to

early afternoon.


38

Patients, who are allergic to grass pollen, may wear a surgical type mask while

moving in lawn or garden.

Use of an air conditioner to prevent air born pollen from entering the home

Patients who have perennial symptoms, down-filled comforters and wool

blankets may be kept away.

Washing of all sheets, mattress pads, pillowcases, and blankets every week in

hot water and detergent; this removes >95% of allergens.15

Wash bedding with hot wash (>550C) or eucalyptus oil to kill dust mites.15

Ensure rooms are well ventilated.15

Remove carpet and replace with washable, hard flooring.15

Remove extra soft furnishing and toys.15

According to Zakaria al Razi and Jalinoos, cupping over the nape of the neck is

advisable for itching in the nose and sneezing.2

Initial stage: adopting symptomatic measures:

Try to expel the mad’da 19, 47 by Inkibab with Banafsha, Nilofar, Nakhuna and

Babuna, 20 and apply fateela in the nose to divert the mad’da from throat or

chest.19, 47

Fasd is advisable if damavi khilt is involved 19, 20 followed by mushilat.20

Lateef ghiza like maushaeer 20

Munzijat 20

Hammam by luke warm water 20 is advisable before prescribing munzijat.2

Snuffing by luke warm shoneez and zeera.20

Should not use any medicines to arrest sneezing, this may interfere with the

nuzj of the mad’da, leading to collection of fuzlat in the brain.19


39

USOOLE ILAJ

Effective treatment of Nazla Haar depends upon accurate clinical diagnosis and

assessment of the patient’s dominant symptoms. Although avoidance of interventions

can reduce extrinsic and intrinsic factors (allergen), they often fail to produce

clinically significant improvement as a result complete therapy is frequently

required.24

1. Izale sabab (Elimination of the cause)

Exposure to heat and / cold (intrinsic and extrinsic factors) should be

eliminated.

2. Correction of Sue mizaj:

I. Sue mizaj sada should be modulated with appropriate regimen and barid

makulat wa mashrubat, roghaniyat, nutulat, zimadat, quturat etc

II. Sue mizaj mad’di should be corrected through munzijat followed by Tanqia. 19

3. Ta’deele mizaj

4. Tadabeer:

Inkibab (steam inhalation), takmeed (fomentation), fasd (venesection) and use

of suitable oils for qutoor (nasal drops).

5. Ghiza:

Precaution from oily, ghaleez lesdaar and delayed digestible foods, meat,

alcohol, onion, garlic, mustard, tea, pista; sour things like milk, curd along

with ghaleez and saqeel ghiza

6. Muqawwiyate dimagh wa med’da 11


40

Common single drugs used in Nazla are: 6, 20, 21

Banfsha, Behidana, Unnab, Sapistan, Asalussoos, Aalubukhara sheerin, Turanjabeen,

Tukhme khitmi muqashar, Kishneez khushk, Barg wa gule aazad, Gulab sufaid, Injeer

siya, Maghze khiyar shamber, Sheere tukhme kahu muqashar, Sheere maghze kaddu,

Maghze badam.

Compound drugs used in Nazla are: 6, 20, 21, 47

Sharbate banfsha, Sharbate khashkhash, Khameere khashkhash, Laooqe sapistan,

Laooqe khashkhash, Luabe behidana, Sharbate unnab, Habbe shifa, Khameere

gauzaban, Triyaqe nazla, Sharbate fardyaris.

Drugs used in modern medicine for rhinitis (Nazla): 24

Antihistamines: Antihistamines are the oldest drug used to treat allergic rhinitis and

are considered first- line therapy. Antihistamines compete with histamine for the H1-

receptor sites that contribute to sneezing, itching, rhinorrhea, and conjunctivitis. Oral

antihistamines ameliorate these symptoms of AR but generally do not improve nasal

congestion.

Decongestants: Decongestant such as pseudoephedrine treats nasal stuffiness but is

mild stimulants. These drugs are usually used in combination with antihistamines to

control the full spectrum of AR symptoms. Antihistamines and decongestant alone

generally do not provide satisfactory relief in patients with moderate to severe AR.

Leukotrienes Modifiers: leukotrienes modifiers (zafirlukast, montelukast, zileuton)

have conformed efficacy in AR comparable to that of antihistamines. This efficacy

reflects the presence and importance of these pro-inflammatory vasoactive mediators

in AR. Zafirlukast significantly reduces sneezing, rhinorrhea and in contrast to

antihistamines- nasal congestion in patients with SAR. Similarly, montelukast


41

significantly improves nasal and ocular symptoms as well as quality of life in patients

with SAR and PAR.

Nasal Cromolyn: Nasal Cromolyn stabilizes mast cells and mediates additional anti-

inflammatory activities towards macrophages and T lymphocytes. Although not as

effective as intranasal corticosteroids, Cromolyn provides relief in patients with mild

to moderate symptoms, and it may be effective in combination with corticosteroids in

the treatment of refractory symptoms.

Intranasal corticosteroids: Intranasal corticosteroids (fluticasone, triamcinolone,

flunisolide, budesonide, mometasone, and ciclesonide are the most effective AR

treatments and are considered the treatments of choice for patients with moderate to

severe SAR or PAR, due to the potential side effects of systemically administered

corticosteroids, topical nasal steroids. 66 Topical corticosteroid therapy does not

inhibit IgE synthesis or mast cell degranulation. Intranasal corticosteroids are not

universally effective and do not provide complete relief in all patients.

Immunotherapy: immunotherapy decreases the severity of AR, reduces the need for

pharmacotherapy, and significantly improves quality of life. In patients with severe

AR and conjunctivitis poorly controlled by antihistamines and intranasal

corticosteroids, immunotherapy can reduce allergen sensitivity by more than 10-folds,

as well as significantly decreasing total symptoms and reducing total antiallergic drug

usage.

Surgery: rhinitis is due to anatomical component to the disease such as nasal septal

deviation or nasal polyps, or even sinusitis surgery may be indicated. 15


42

BEHIDANA

Behidana is the seeds of Behi (Quince);

they are black or red in colour.67 Behi

is a shrub, small cultivated deciduous

tree, rather bushy 68, 69, 70 and

indigenous to Persia; 69, 70 growing up

to 8 meters, 68 but distributed

throughout Europe and other

countries.69, 70 It is cultivated in

Afghanistan, North West Frontier province.69, 70 It is grown in Kashmir, Himachal

Pradesh and the Nilgiris at an altitude of 1700m.71 Flowering and fruiting take place

during August – September.70 Behi leaves are simple, entire, stipules oblique, ovate.

Flowers are solitary, white or pink, wooly, large. Fruits are pear or apple shaped

sweet smelling, yellow in colour, juicy, fragrant, and contain a large number of plano-

convex, mucilage- coated seeds, closely packed in two vertical rows, in each of the

five carpellary cavities of the fruit.68, 71, 72 The dried seeds (Behidana) are irregularly

ovoid, plano-convex and three ribbed. 68 The behidana (Quince seeds) has been used

as a medicine since ages 73 as a laxative, astringent and anti inflammatory.74

Botanical Name: Cydonia oblonga Mill. 68, 69, 71, 72, 75- 83

Family: Rosaceae 68, 69, 71, 72, 76-80, 82

Vernacular name:

Arabic: Habb-us- Safarjal; 67, 70, 81 Persian: Behidana,70 Behi;8, 84 Urdu: Behidana;69

English: Quince, 68 -72, 77 Quince seed, 81, 83 Common Cydonia; 69 Hindi: Bihi; 69, 71, 75,

78, Sanskrit: Amritphala; 70, 75, 78 Kannada: Simodalibe; 69, 70 Tamil: Shimaimathala;


43

69, 71, 75, 76, 78, Telugu: Simadanimma; 69, 70, 75 Kashmiri: Bamsutu; 70, 75, 78 Unani: Bihi,

76 Bihidana, 72 Safarjal; 69 Bengali: Bihidana 71

Mizaj: Sard wa Tar 2o 67, 69, 70

Parts used: Seed, 68-72, 75-78 buds ,69, 78 bark, leaves, 69, 76, 78 fruits, 68, 69, 71, 75-

78, 82

Af’al (Actions):

Dafe nazla, Dafe sual haar, 69, 70 Dafe diq, 69 Muzliq, Mufarrih, 81 Mulattif , 69, 70, 72

Musakkine hararat, 67, 69, 70, 81 Qabiz, Mulayyan, Muqawwie bah, 67 Mushtahi,

Mufattih, Muqawwie med’da.85

Nafae Khas (Main Action):

Ishaal haar, 81 Mufarrih, Muqawwie dil wa dimagh 84

Iste’malat (Uses):

Nazla haar, 70, 81 Amraze khushunate halq, 69, 70, 81, 83 Sual yabis (dry cough),

Khushunate qasbaturriya, 67 Sil wa diq, 67, 81 Kasarate ataas, 85 Humma, 81 Zaheer,

Humuzate medda, 70 Qarhe ama, 69, 70 Amraze safravi, 67, 69 Qae balghami, Sozishe

baul, Nafsuddam, 67 Taskeene hararat, 84 Sozishe zaban, 67, 81 Peechish.69, 81

Miqdare khurak (Dosage):

Seeds 3- 5 Mashas (grams) 81, 85

Mazarrat (Adverse effects):

Mujaffif wa Murkhi med’da, 81, 84 Zoafe med’da wa kulliya 67

Muslih (Correctives):

For Garmi med’da – Kahnd; and Sardi med’da –Misri, 67 Qand sufaid, Badiyan,

Saunf 69; Shakkar and Badiyan.81


44

Badal (Substitute): Isapghol 67, 69, 81

Murakkabat (Compound formulations):

Laooqe behidana, Banadiqe buzoor, Sharbate ejaz, 69, 70 Jawarishe safrjal, 69 Habbe

shaqeeqa, Habbe sil, Habbe surfa qavi, Qurse kaknaj, Laooqe nazli, Laooqe sapistan,

Laooqe shamoon.70

Ethanobotanical Description:

Actions:

Expectorant, 71, 82 soothing, 76 astringent, cardiac tonic, antispasmodic, 82 demulcent,

71, 72, 75, 76, 78, 82 laxative.68, 77

Therapeutic Uses:

Internally it is used in diarrhea, dysentery, 71, 72, 76, 78 constipation, 76 sore throat, 71-73, 78

fever, 71, 72, 78, gonorrhea, inflammation of the mucous membrane, 71 bronchitis. 68, 73, 77

Externally it applied in ulcers, burns and scalds.71, 73, 74, 76, 78

Chemical Composition:

Fixed oil, 68-70 cyanogenic glycosides, 68, 82 glycoside amygdalin, 72,76, 78 tannins, 68-70,

72 , 76mucilage, 68, 72, 76, 82 fatty oil, 76 ash, 72, 76 glucuronic acid residues, 80 volatile oil,

iron, calcium, phosphorus, magnesium, potassium, glycoside, steroid, protein, 69, 70

glucoside, amygdalin, ursolic acid, roseoside, mixture of n-paraffins, alcohol-

soluble extractive(s), β-sitosterol, saringosterol, palmitic, oleic, linoleic, and

marmelolactones A & B.70


45

Scientific Reports:

1. An in vitro study has shown that Citrus and Cydonia compound can

potentially restore the disturbed immune state of rhinitis patients, which

essentially could be sufficient to make allergic symptoms disappear

permanently.86

2. A recent study has shown that a positive effects by Citrus and Cydonia

compound on allergic to grass pollen, suffering from hay fever, and the

necessity for the use of antihistamines with regard to the nature of the

complaints.86

3. A study has shown that Citrus and Cydonia compound is being prescribed

over eighty years as a subcutaneous injection or as a nasal spray for patients

who suffer from seasonal allergic rhinitis.86

4. The hot water extract of quince (Cydonia oblonga) has an inhibitory effect on

broad range of the late phase immune reactions of mast cells.87

5. The phenolic extract of quince leaf has properties of free-radical scavenging

and anti haemolytic activities.88

6. The phenolic extracts from leaves of Cydonia oblonga can be used as a better

and cheaper source of bioactive compounds and may have relevance in the

prevention of diseases in which free radicals are implicated.89

7. The leaves of Cydonia oblonga has been utilized in traditional medicine as

antitussive, antipyretic, sedative and antidiarrheic properties.89

8. The polyphenolic extracts of fruit from Cydonia oblonga has been proved that

it has antioxidant, antimicrobial (antibacterial and anti- influenza viral), and

anti ulcerative properties.89


46

9. The methanolic extract of fruit of Cydonia oblonga has been proved that it has

antioxidant properties against oxidative haemolysis of human erythrocytes.90


47

UNNAB

Unnab (Indian jujube) is a fruit of a well

known plant Zizyphus jujuba. The Indian

jujube is a spiny deciduous shrub or a

small tree commonly 6 to 10 meters high,

68, 91 usually armed; young branches and

flowers densely tomentose.71 Leaves are

alternate, elliptic ovate or sub orbicular to

ovoid- lanceolate, 68, 71 dark green and

glabrous above, slightly velvety beneath by pale-brown tomentum. 71 Flowers perfect

and axillary clusters or shortly peduncled cymes 71; 7-8 flowers in each cluster,

greenish yellow.68 The fruit has two varieties; the wild is small and round, while the

cultivated fruit is oval, fleshy, bigger in size and sweeter than the wild. 92 The

cultivated variety when ripe and dry is expectorant and mild laxative. Drupes 1.5-5cm

long, ovate to oblong, dark reddish- brown when ripe, containing a single stone

surrounded by 2 celled fleshy pulp, glabrous, edible. Seeds are plano- convex. 71 The

bark, wood and fruit come from Jurjan, China, and Nepal; the fruit is sweet and

moderately astringent about the size of a dried date with a small stone.93 Flowering

and fruiting take place during September to October.68

Unnab is indigenous and naturalized throughout India, 78 and in the outer Himalayas

altitude up to 1,350 meters; 76, 78 commonly cultivated in India, Japan, China, Africa,

Malaysia, Afghanistan and Australia.68

Botanical Name: Zizyphus jujube Mill. 68, 71, 75- 78, 80, 91, 93-95

Family: Rhamnaceae 68, 75-78, 94


48

Vernacular name:

Arabic: Unnab; 96 Persian: Sailanah; 97 English: Indian jujube, 71, 76, 77 Common

jujube; 68, 76, 77 Hindi: Baer, 75, 91 Ber, 71, 75, 77, 91 Beri; 77, 91 Sanskrit: Ajapriya, 75

Badara, 71, 75, 77 Karkandhu, Kuvala, Maduraphala; 75 Urdu: Ber; 91 Unani: Ber, 76

Unab; 95 Sinhalese: Ilanda; 91 Malayalam: Elantha,75 Ilanta, Ilantappalam, 77

Badaram; 78, 91 Kannada: Yalachi, Elanji, 75, 77 Bore; 77, 78 Tamil: Ilandai, 77, 78, 91, 94

Ilantappalam, 77 Elladu; 71,75 Bengali: Ber, Boroi, 75 Kool; 71, 75 Marathi: Bor,75

Bera; 75, 91 Gujarathi: Bor, Bordi; 75 Telugu: Reegu, 75, 77, 91 Gangareegu, 75, 77, 78, 91

Karakandhavu. 75

Mizaj: Motadil – Haar Barid, 67, 81 Haar Ratab, 97 Barid Ratab 85

Parts used: Fruits, 67, 68, 71, 75-78, 81, 85, 91, 93, 94 seeds, 71, 75, 76 leaves 71, 75, 76, 78,

twigs, 71 barks 71, 76, 78 roots 71, 78

Af’al (Actions):

Musaffie khoon, 67 Mulattif, 85 Munzije akhlate ghaleeza, 81, 94 Mulayyane sadaro

ahasha, 94 Munaffise balgham, 81 Ta’deeluddam, 81, 84 Mulayyane taba’ 81 Mulayyane

akhlate raqeeqa, 84 Muallide khoon, Musakkin.84, 94

Nafae Khas (Main action):

Dafi’ khushunate halq, Musaffie khoon 81


Nazla wa zukam, 81 Sual yabis 84, 97 Ta’deeeluddam , 81, 85 Darde seena, jiger wa

gurda, 84, 85 Khushunate halq, 67, 97, Basoor wa kharash, Musakkine hararat, Taskeene

atash, Aatishak, 81 Khushunate seena.81, 97


49


5- 7 pieces 81, 85


Med’da wa bah, 67, 81 Naf’fakh 67


For Naf’fakh- Kahnd aur Maveez aur Gulab; 67Zoafe bah- Shahed 67

Shaker, Gulab aur Shahed 81

Badal (Substitute): Sapistan 67, 81


Sharbate unnab, 67 Sharbate ejaz, Laooqe sapistan 81


Actions:

Anodyne, 71, 75-77, 80 cooling, tonic, 71, 75-77, 80, 91 astringent, stomachic, 71, 76 styptic, 71,

76-78, 91, 94 antidote to aconite poisoning, 80, expectorant, 71, 76, 93 mild laxative, 71, 76, 91

aphrodisiac, 77, 91 appetizer, 77 mucilaginous, 77, 78, 91, 94 nausea and vomiting, 80

digestive, 78, 91, 94 purgative, 77 nutrient, emollient, 76, 80 antitussive, anti allergic, 76

blood purifier. 78, 91, 93, 94

Therapeutic Uses:

Internally for skin diseases, 77, 91 purify blood, aid digestion, 78, 91, 94 useful in vitiated

condition of pitta, constipation, heamorrhages, flatulence, dyspepsia, 77 diarrhoea,

night sweats, hysteria, palpitational insomnia, general fatigue, 68, 77 vomiting, 77, 81, 91

hyperdipsia, 77, 91 removes biliousness, 91 nausea, 77, 80 abdominal pain in pregnancy. 80

Externally used in wounds, ulcers. 77, 80


50


Carbohydrates, protein 68, 98 amino acids, anthocyanins, fat, 68 linoleic acid, myristic

acid, palmitic acid, β-sitosterol, stigmasterol, 71 calcium, phosphorus, iron, carotene,

thiamine, riboflavin, niacin, vitamin C, ziziphic, 98 cyclic AMP and GMP, saponins,

jujuboside B, alphitolic acid, 76 mucilage, sugar, 93 tannin, 80, 98

Scientific Reports:

1. The anti-allergic activity of aqueous extracts of Z. jujuba was studied by

measuring its inhibitory effect on hyaluronidase (bovine testes) activation in

vitro. Z. jujuba was shown to have strong anti-allergic activity (Su et al.,

2000). 92

2. The study has proved that the essential oil from seeds of Z. jujuba has a useful

anti-inflammatory agent, and the anti-inflammatory effects of the major

pharmacological components present in the essential oil of Z. jujuba seeds

might accelerate the development of new drugs for various inflammatory

diseases. 99


51

SAPISTAN

Sapistan is an edible 75 fruit of Cordia

dichotoma, which is a well known

drug used in Unani system of

medicine. This plant being perennial,

found throughout year.69 It is a

moderate 69 or medium 68 sized,

deciduous tree about 13- 14m high

with a short crooked trunk; 69, 71

leaves simple, 68 alternate, variable in form and size, 71 entire or slightly dentate,

elliptic-lanceolate to broad-ovate or oblong sub-3-nerved, 68, 69 with a rounded or

cordate base.68 Flowers white, 68 borne in many-flowered, 71 small in lax corymbs, 68,

69, 71 terminal or axillary cymes, 68 polygamous, hermaphrodite.71 Calyx glabrous or

minutely pubescent 68 without lobes; 69 fruits drupes, 68 berries, ovoid, subacute, 71

yellowish brown, pink or nearly black when ripe with a viscid sweetish; transparent

pulp surrounding a central stony part 68, 71 usually 1 seed.69, 71

The Cordia dichotoma grows throughout India in the warmer regions.68, 79 The fruits

are used extensively due to diverse pharmacological actions and therapeutic uses

attributed to it. Although, its leaves, bark and kernels are also having medicinal

importance but, fruits are mostly used for medicinal purposes as astringent,

anthelminitc, demulcent, diuretic, and expectorant hence used in diseases of chest and

urinary passage. 75 Flower appears in March- April the fruit ripens in May to July.69

Botanical Name: Cordia dichotoma Forst. f 68, 69, 71, 76-78, 97

Family: Boraginacae 68, 69, 71, 76-78


52

Vernacular name:

Arabic: Dabaq;91 Persian: Sapistan; 79, 91 English: Sebestan plum, 91Sebestan fruit; 79

Hindi: Lasora, 75, 79, 91 Chota lasora; 75, 91 Sanskrit: Bahuvaraka; 75, 91 Urdu: Lasora;

91 Malayalam: Viri, 75 Cheruviri; 75, 91 Kannada: Chikkachalle; 75 Tamil:Naruvili 75,

91 Bengali: Bahubara, 75, 91 Bal-phal; 79 Gujarathi: Bargund, 75 Lepistan; 91 Telugu:

Chinna Nakkeru; 75, 91 Marati: Shelvant; 75

Mizaj: Motadil 67, 69

Motadil in Garam wa Sard 85, 98

Parts used: Fruit 67, 68, 71, 75, 76, 78, 79, 91, 93 bark, 68, 76-79, 91 leaves, 68, 76-78, 91

seeds 76, 91

Af’al (Actions):

Mulattif, Mudire baul, 69, Musakkin, 67, 69 Mulayyan, Munaffise balgham, Muzliq 81

Nafae Khas (Main actions):

Sual yabis 81


Nazla haar, 81 Khushunate halq, Zatul jenb, Shosa, Barsam, 67, 81 Varme halq, Sozishe

ama , Darde seena, Ishaale safra and sawda, Ta’deeluddam 67 wa safra, 67, 81

Taskeene atash, Sozishe baul, Sual yabis, 67, 81, 97 Khushunate seena, 81, 97 Aathsak,

Sozak, 69, Qatile kirme shikam, 67, 97 Hummiyat safravi wa damavi, Mulayyane taba, 81

Hummiyate harra. 97


9- 15 pieces 81, 85


53


Zoafe med’da wa jigar 67, 81


Unnab, Amla 67 wa barge gulab 81

Badal (Substitute):

Khitmi 67, 69, 81 or Unnab 67, 69


Laooqe sapistan 69, 98


Actions:

Astringent, 71, 75, 76, 78, 91 expectorant, anthelminitc, diuretic, 68, 71, 75-78, 91 demulcent, 71,

75, 76, 78, 79 mucilaginous, 76, 79 cooling, purgative 68, 77, 91 aphrodisiac, emollient,

febrifuge.68, 77

Therapeutic Uses:

Internally; disease of chest, 71, 75, 76, 78, 79, 81 spleen 68, 71, 75, 77, 78, 91 and urinary passage,

71, 75, 76, 78 dyspepsia, 91 dry cough, chronic fevers, arthralgia, 68, 76, 91 diseases of

uterus, 79 scolding of urine, burning sensation of the throat, 91 vitiated conditions of

vata and pitta, leprosy, skin diseases, bronchitis, strangury, urethralgia, urethritis, 68,

77 disease of urethra.79, 91 External application - ringworm, ulcers 68, 77


Carbohydrates, 69, 80 crude fibre, ash, protein, fat, 80 phenolics, tannins, potassium,

sodium, magnesium, steroids, 69 iron, calcium, 69, 76, 80 phytic acid, phytate

phosphorous, oxalic acid phosphorous, zinc, manganese, chromium, copper.76, 80


54

Scientific Reports:

1. Methanolic extract of Cordia dichotoma seeds and leaves possess powerful

antioxidant activity. 101

2. The plant of Cordia dichotoma has been reported that it possesses analgesic,

anti-inflammatory and hepatoprotective activities. 102

3. Flavonoids contain fruit of Cordia dichotoma has the property of wound

healing.102

4. The seeds of the plant Cordia dichotoma forst f. have been reported that it has

anti-inflammatory property. 103

5. A study shown that the fruits of Cordia dichotoma are used as astringent,

expectorant, anthelminitc, purgative, diuretic, 101, 102, 103 cooling, aphrodisiac,

and emollient. 104


55

BANAFSHA

Banafsha is the flowers of plant

Viola odorata, which is a perennial

stock short, but sometimes branched,

knotted, with the remains of the old

leaf- stalks and stipules, and usually

emitting creeping runners or scions.91

It is a glabrous or pubescent herb,

about 15cm in height. Its root stocks are very stout and stolons are cylindrical. Leaves

are dark green, tough, broadly ovate or cordate in shape with crenate margin. They are

1.5 to 5 cm in size. Flowers are solitary, auxillary forming central flowering rosettes.

Flowers are deep violet in shade with bluish-white base, sweet, scented and hence

plant is cultivated in gardens as an ornamental crop. Flowers have great reputation in

respiratory diseases, and are usually used as sharbat.105 Fruits are in the form of

capsules, round, three angled and often purplish in colour. 69, 105 It is indigenous to

India and found in Kashmir (Kangra), Himachal Pradesh (Chamba), and Kumaon

hills. 105 The plant blooms in second year.69, 101

Banafsha is commonly called as sweet violet and is well known to India for its

medicinal virtues and has been in use since olden times for treating several diseases

both in Ayurvedic and in Unani system of medicine.80 Flowers are used extensively

due to its pharmacological actions and therapeutic uses are ascribed to it; on account

of their demulcent, diuretic and mild laxative properties; in large doses they are

emetic.79


56

The banafsha is available in commerce in three forms: (1) the dried aerial parts of the

herb, viz, the stems, leaves and flowers (Kashmiri banafsha); (2) only the dried

flowers (Gule banafsha); and (3) the aerial parts without flowers (Barge banafsha).80

Botanical Name: Viola odorata Linn. 68-70, 75-79, 83, 96

Family: Violaceae 68-70, 76-79

Vernacular name:

Arabic: Banafsaj, 69, 70, 81, 96 Firfeer; 69, 81, 91, 96 Persian: Gule Banafsha; 70 English:

Sweet violet, 68-70, 76, 77, 83, 105 Violet; 70 Hindi: Banafshah; 68-70, 77, 80 Sanskrit:

Banaphsha, 68, 77 Nilapushpa; 78 Urdu: Gule Banafsha; 69 Malayalam: Vayilettu; 78

Kannada: Violethoo; 68, 77, 80 Tamil: Vilaettu; 68-70, 77, 80 Bengali: Banafshah, 68-70, 77, 80

Banosa; 69, 80, 81 Marathi: Bagabanosa; 69, 70, 80 Gujarathi: Bahaphsa 69, 70, 80 Telugu:

Vialettu; 70 Kashmiri: Banafsha; 70 Unani: Banafshaa, Banafsaj 76

Mizaj: Sard wa Tar 1o 8, 67, 70, 100

Garam wa Khushk 1o 69

Parts used: Flowers, 68-70, 76, 80, 91, 96, 106 leaves, 76, 80, 83, 96 roots 78, 80, 91

Af’al (Actions):

Mulayyan, 8, 67, 69, 70, 81, 85 Mushil, Latafat, Lazoojat, Jazib, Muzliq, Islahe khoon, 67

Munaffise balgham Muhallile warm 69, 70, Muaddile safra, Musakkine khoon 81,

Murattib wa munavvim 8, 81

Nafae Khas (Main Action):

Mulayyane taba’81


57


Zukam, 81 Nazla, Suaal 69, 70, 81, Mukharije safra, 85 Qabz, 67, 69, 70, 81 Ie’tidale safra, 67,

81 Tahleele lateef aur sakht warm, 67 Zatul jenb, Sudae haar, 81, 85 Saher,

Ta’deeluddam, Aashoobe cheshm, Humma, Taskeen atash, Zaturriya, Amraze haara

med’da wa jigar, 81 Darde kulliya 85


Flowers 10gm or 20gm 67, 69

10-25gms70


Mukarrab, 67, 81, 84 Matli 67


Marzanjosh, 69, 81, 84 Nilofar 81, 84

Badal (Substitute):

Gule nilofar, 67, 69 Barge khubbazi, 67, 81 Asalussoos, 67, 69, 81 Rube soos, 67 Gauzaban 81


Sharbate banafsha, 67, 70, 81, 95 Sharbate ustukhuddus, Sharbate arzani, 95 Khameere

banafsha, Roghane banafsha, 67, 70, 95 Habbe banafsha, 81 Itrifale zamani, 70, 95 Habbe

sil, Majoone antaki, Mufarre motadil, Mufarre yaqooti barid, Zimade warme

unsayain, Sharbate ejaz, Dayaqooza, Qairooti muhallil, Habbe ghariqoon, 70 Laooq

sapistan Khiyar shamberi.95


58


Actions:

Expectorant, diuretic, 76, 93 anti-inflammatory, diaphoretic, antipyretic, 76 emollient,

demulcent, 78, 80, 91, 95 purgative, 93 febrifuge.78

Therapeutic Uses:

Biliousness, 78, 93 lung troubles, 78 catarrhal and pulmonary affections, diseases of liver

and intestine, 76 cough, hoarseness of voice, infantile ailments, 80, 91 sore-throat, 68, 77,

80, 91 fever, 68, 77 cancerous growth pain particularly in the mouth and throat.80


Volatile oil, 80, 93, 95 violin, 68, 80, 93, 95 rutin, cyanin, 80, 95 emetine, violenic acid, 93

voilanin chloride, 76 anthocyanin, tocopherol, flavonoids, mucilage, ash, 76 methyl

salicylate, sugar, 80 salicylic acid, 93 saponins, glycosides, phenolic compounds,

tannins, resins, triterpines, potassium, magnesium, sodium, iron.69

Scientific Reports:

1. An aqueous extract of Viola odorata has been proved that it has anti

inflammatory property equal to corticosteroids in the treatment of

inflammatory conditions of the lung. 107

2. The extracts of phenolic compounds and flavonoids of Viola odorata Linn.

have been proved to possess antioxidant and free radical scavenging activities.

108

3. The herb Viola odorata shows antimycotic and antibacterial activity, and is

considered quite effective in the treatment of eczema.80

METHODOLOGY

Methodology

59

MATERIALS AND METHODS

The present clinical study entitled “Efficacy of a Unani formulation in Nazla Haar”

was conducted after enrolling the patients from outpatient department of National

Institute of Unani Medicine hospital, Bangalore, after the approval of the NIUM,

Institutional Ethical Committee for Biomedical research during March 2011 to

December 2011.

1. Criteria for selection Patients

Known case of Nazla Haar, and or patients having the symptoms like sneezing,

watery nasal discharge, sensation of nasal obstruction, itching sensation in the nose,

mouth or throat, tearing of the eyes, were carefully evaluated, based on the criterion

of inclusion and exclusion.

a. Inclusion criteria

Age between 12-50 years

Gender: males and females

Diagnosed patients of rhinitis

Patients with symptoms complex that consists of any combination

of the following: sneezing, rhinorrhea, nasal congestion, itching in

the nose, eyes, throat or mouth, postnasal drip and headache.

Patients who have agreed to sign the informed consent form and

follow the protocol.

Methodology

60

b. Exclusion criteria

A. Physiological status

Patients below 12 and above 50 years of age.

Pregnancy and lactating women

B. Pathological status

Atrophic rhinitis

Sinusitis

Deviated Nasal Septum

Nasal polyps/ Nasal growth/ Adenoids

Asthma

Patients with systemic diseases like diabetes mellitus,

cardiovascular, impaired renal and hepatic functions

C. Patients who refuse to give the written informed consent for the study.

2. Selection of patients

Patients fulfilling the inclusion criterion were subjected to haematological,

biochemical and radiological investigations for obligatory terms of inclusion criteria,

were enrolled in the study after obtaining a voluntary written informed consent.

a. History Taking

A detailed history was recorded based on their chief complaints with duration, age,

sex, religion, marital status, occupation, address, socio economic status on the basis of

Kuppuswamy’s socioeconomic scale.109 Personal history, treatment history, past

history of any disease, family history was also recorded in a predesigned and pretested

proforma.

Methodology

61

b. Examination:

Each patient was subjected to comprehensive general physical and systemic

examination with special emphasis on pulse, blood pressure, respiratory rate,

temperature, built, height, bodyweight, cyanosis, clubbing of fingers, mouth

breathing, lymphadenopathy and icterus etc. Likewise, careful systemic and local

examinations were also done to rule out for any findings and involvement of any other

serious illnesses. A thorough local examination of nasal cavity was performed for

colour of mucosa, swelling of turbinates, colour & consistency of nasal discharge and

nasal obstruction.

c. Investigations:

Investigations such as Hb%, TLC, DLC, ESR, RBS, RFT, LFT, X-ray PNS and Nasal

smear for eosinophils were carried out in all enrolled patients before and after

completion of the treatment, to exclude the patients other than Nazla Haar, to

establish the safety of the drugs (test and placebo), and as an objective parameters.

d. Assessment of Mizaj:

The Mizaj of the patients was determined on the basis of Ajnase ashra.

3. Informed consent

Patients fulfilling the inclusion criteria were asked to refer thoroughly the Informed

Consent sheet, which possess the details of study, including nature of drugs or

procedure administered, and its risk and benefits; moreover, the patients association

with the study is purely voluntary, they can ask any information / query with the

investigator. After the acceptance by the patients without any coercion asked to give

written informed consent duly signed with date.

Methodology

62

4. Method of Collection of Data:

Through clinical study of patients enrolled into the study from the OPD and IPD,

NIUM, Bangalore.

5. Study design:

Randomized, single blind, placebo controlled clinical study.

6. Sample size:

40 patients

7. Allocation of subjects into groups:

The 40 patients were randomly allocated into two groups comprising 30 patients in

test and 10 in placebo control group.

8. Duration of protocol:

15 days in both test and control groups.

9. Criteria for selection of drugs:

The Unani formulation consists of Behidana, Unnab and Sapistan in the form of

Joshanda along with Sharbate Banafsha 110 has been in use since a long time and

claimed its efficacy in Nazla Haar. Therefore, this formulation was selected from the

Bayaze Kabeer to validate its efficacy and safety.

The ingredients of Joshanda110 and Sharbate Banafsha 110, 111 along with their

dosage are given below:

Methodology

63

SI. Name of the drug Botanical names Doses

1. Behidana Cydonia oblonga 3gm

2. Unnab Zizyphus jujube 5 pieces/ 7.5gm

3. Sapistan Cordia dichotoma 9 pieces/ 9gm

Sharbate Banafsha

SI. Name of the drug Botanical names Doses

1. Gule Banafsha Viola odorata 125gm

2. Qande Sufaid Saccharum officinarum 1000gm

10. Method of preparation, dosage and mode of administration of test drug:

Good quality crude drugs were procured from the local market; it was identified and

ascertained as the authentic crude drugs. The crude drugs were crushed to coarse

powder for making Joshanda, and Sharbate Banafsha was prepared under the

supervision of the Chief Pharmacist, NIUM, Pharmacy following Good

Manufacturing Practice. Later the Joshanda powder was packed in self locking

polythene pouches of 20gm and Sharbate Banafsha 50ml per day dosage packed in

plastic container, whereas the caramel syrup was served in same quantity in bottles for

the same duration as similar to test group.

11. Follow ups

The study duration was fixed as 15 days with 3 follow ups i.e. on 4, 8, and 15 days. At

every visit, patients were asked about the effects of the drug administered and

subjected to assess clinically.

Methodology

64

Concomitant treatment was not allowed during treatment in both groups. The patients

who were taking any other medicine as a treatment of Nazla Haar were advised to

observe abstinence for a week from consuming those drugs before commencing

treatment with the test or placebo.

12. Efficacy assessment:

Efficacy assessment was made subjective and objectively at each follow up with

reference to baseline symptoms up to 15th day of the treatment. Total Symptom

Severity Score (TSSS) is an objective method used in assessing the efficacy of the

study. The severity of 8 symptoms (rhinorrhoea, sneezing, nasal congestion,

itchy nose, itchy mouth or throat, lacrimation, post nasal drip and headache) was

rated on a 4 point scale (0-absent, 1- mild, 2- moderate, 3- severe). 112, 113, 114, 115

These scores were summed for each patient at each assessment point (based on the

involvement of the subjective parameters), to obtain a TSSS, with a maximum value

of 24 points. TSSS score of both, test and placebo control groups, was calculated

according to the method described by Rogkakou et al. 114

Therefore in each follow up, the patients were asked to rate the severity of their nasal

symptoms (sneezing, rhinorrhea, nasal obstruction and itching in the nose, mouth or

throat) and ocular symptoms (itchy eyes and watering of the eyes) on a four point scale

for each symptoms along with the side effects occurred during the treatment period.

Methodology

65

Symptom Evaluation Scale

Description Definition

0 None No symptom

1 Mild Symptom present, but does not bother the

patient

2

Moderate

Symptom moderate, but does not prevent the

patient from carrying out normal activity nor

interfere with sleep

3

Severe

Symptom severe, and prevents the patient

from performing normal activities and/or

interferes with sleep.

13. Withdrawal criteria: a. Failure to follow the proforma

b. Any adverse drug reactions

c. Drug defaulters

14. Safety assessment: The assessment of the safety of the treatment was made on

the basis of:

1. Clinical findings

2. Hematological assessment (before and after treatment)- Hb%, TLC, DLC,

and ESR

3. Biochemical assessment (before and after treatment)

LFT (SGOT, SGPT), RFT (Blood urea, S. Creatinine).

14.1 Criteria for safety evaluation: Non occurrence of any adverse effect during

the treatment period along with significant difference in the haematological and

biochemical laboratory values.

14.2 Adverse drug documentation: No any adverse effect occurred.

Methodology

66

15. Methods: Adhered to the Good Clinical Practice (GCP).

16. Documentation: After completion of the study the case report form (CRF) along

with Informed consent forms will be submitted to the Department of Moalajat,

NIUM, Bangalore.

17. Statistics: The overall response was assessed by u s ing statistical tests like

Paired, Fisher’s exact test two tailed, Friedman, and Kruskal- Wallis with

Dunn’s Multiple Comparison.

RESULTS

Results and Observations

67

Table 1

Distribution of patients according to Age

n=40

Age

No. of Patients

Total No. of Patients

Percentage %

Test Group

Placebo control

Group

13-20

6

2

8

20

21-30

11 4

15

37.5

31-40

8

2

10

25

41-50

5

2

7

17.5

Total

30

10

40

100

02468

10121416

13-20 21-30 31-40 41-50

8

15

10

7

Graph-1: Distribution of patients according to Age


68

Table 2

Distribution of patients according to Sex

n= 40

0

5

10

15

20

25

Male Female

25

15

Graph-2: Distribution of patients according to Sex

Sex

No. of Patients


Percentage

%

Test Group

Placebo Control Group

Male

19

6

25

62.5

Female

11

4

15

37.5

Total

30

10

40

100


69

Table 3

Distribution of patients according to Marital Status

n=40

Marital status

No. of Patients


Percentage %

Test

Group


Married

18

8

26

65

Unmarried

12

2

14

35

Total

30

10

40

100

0

5

10

15

20

25

30

Married Unmarried

26

14

Graph-3: Distribution of patients according to Marital Status


70

Table 4

Distribution of patients according to Religion

n=40

Religion

No. of Patients

Total No. of

Patients

Percentage %

Test Group


Hindu

16

06

22

55.0

Muslim

13

04

17

42.5

Christian

01

00

01

2.5

Total

30

10

40

100

0

5

10

15

20

25

Hindu Muslim Christian

22

17

1

Graph-4: Distribution of patients according to Religion


71

Table 5

Distribution of patients according to Dietary Habit

n=40

Dietary habit

No. of Patients Total No. of

Patients

Percentage %

Test Group


Vegetarian

1

3

4

10

Non vegetarian

29

7

36

90

Total

30

10

40

100

90%

10%

Graph-5: Distribution of patients according to Dietary Habit

Non Vegetarian

Vegetarain


72

Table 6

Distribution of patients according to Socio Economic Status (SES)

n=40

SES

No. of Patients


Percentage %

Test Group


Upper

02

01

03

7.5

Middle

27

08

35

87.5

Lower

01

01

02

5.0

Total

30

10

40

100.0

7.5%

87.5%

5.0%

Figure-6: Distribution of patients according to SES

Upper

Middle

Lower


73

Table 7

Distribution of patients according to Mizaj

n=40

0

5

10

15

20

25

DamaviBalghami

SafraviSawdavi

16

24

00

Graph-7: Distribution of patients according to Mizaj

Mizaj


Patients

Percentage %

Test Group

Placebo Control

Group

Damavi

9

7

16

40

Balghami

21

3

24

60

Safravi

0

0

0

0

Sawdavi

0

0

0

0

Total

30

10

40

100


74

Table 8

Distribution of patients according to Family History

n=40

Family History

No. of Patients Total No. of Patients

Percentage %

Test

Group Control Group

Positive

9

3

12

30

Negative

21

7

28

70

Total

30

10

40

100

0

5

10

15

20

25

30

Positive

Negative

12

28

Graph-8: Distribution of patients according to Family History


75

Table 9

Distribution of patients according to Occupation

n=40

0123456789

1010

7

4

7

43

5

Figure-9: Distribution of patients according to Occupation

Occupation

N0. Of Patients Total No. of Patients

Percentage % Test Group Control Group

Students 9 1 10 25 Businessmen 3 4 7 17.5

Teachers 4 0 4 10 House wives 3 4 7 17.5

Tailors 4 0 4 10 Mechanics 2 1 3 7.5

Others 5 0 5 12.5 Total 30 10 40 100


76

Table 10

Distribution of patients according to Duration of Illness

n=40

0

2

4

6

8

10

12

14

16

12

16

6

4

1 1

Figure-10: Distribution of patients according to Duration of Illness

3 months-1 year 2-4 Years 5-7 Years 8-10 years 11-13 Years 14-16 Years

Duration of Illness

No. of Patients Total No. of Patients

Percentage %

Test

Group Control Group

3 months – 1 year 7 5 12 30 2-4 years 14 2 16 40 5-7 years 5 1 6 15 8-10 years 2 2 4 10 11-13 years 1 0 1 2.5 14-16 years 1 0 1 2.5 Total 30 10 40 100


77

Table 11

Distribution of patients according to Treatment History

n=40

Treatment History

No. of Patients


Percentage %

Test Group


Positive

28

9

37

92.5

Negative

2

1

3

7.5

92.5%

7.5%

Graph-11: Distribution of patients according to Treatment History

Positive Negative


78

Table 12

Distribution of patients according to Seasonal variation

n=40

Seasonal variation

No. of Patients


Percentage %

Test Group


Seasonal

17

5

22

55

Perennial

13

5

18

45

Total

30

10

40

100

55%

45%

Graph-12: Distribution of patients according to Seasonal variation

Seasonal

Perennial


79

Table 13

Distribution of patients according to Effect of Allergens

n=40

Allergen


Patients

Percentage %

Test Group

Placebo Control

Group Dust 11 3 14 35

Dust+ Cold 10 7 17 42.5

Dust+Smoke 5 0 5 12.5 Others 4 0 4 10 Total 30 10 40 100

0

2

4

6

8

10

12

14

16

18

Dust Dust + Cold Dust+ Smoke Others

14

17

54

Figure-13: Distribution of patients according to Effect of Allergens


80

SUBJECTIVE PARAMETERS

Table- 14: Effect of drugs on Rhinorrhoea (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days

0th day 4th day 8th day 15th day Test Group

2.1±0.19 2.5{0,3}

1.3±0.19 1{0,3}

0.6±0.15 0{0,3} a

0.26± 0.13 0{0,3} a, b, c, d, e


1.4 ±0.22 1{1,3}

1.4±0.22 1{0,3}

1.5±0.22 1{1,3}

0.9±0.23 1{0,2}

n=30 in test and 10 in placebo control groups. Friedman Test is used for intra-group comparison and Kruskal-Wallis with Dunn’s multiple comparison pair tests for inter-group comparison.

a- P<0.01 very significant w.r.t. test day 0, b- P<0.01 very significant w. r. t. test day 4, c-P<0.05 significant w.r.t. placebo day 0, d- P<0.05 significant w.r.t. placebo day 4, e- P<0.01 very significant w.r.t. placebo day 8.

0

0.5

1

1.5

2

2.5

0th day 4th day 8th day 15th day

Test Group


Graph-14: Effect on Rhinorrhoea


81

Table- 15: Effect of drugs on Sneezing (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days

0th day 4th day 8th day 15th day Test Group

2.16±0.19

3{0,3} 1.13±0.19 1{0,3} a

0.6±0.15 0{0,3} b

0.26±0.12 0{0,3} b,c,d,e,f


1.7±0.33 1.5{0,3}

1.7±0.33 1.5{0,3}

1.4±0.26 1{0,3}

1.1±0.27 1{0,3}

n= 30 in test and 10 in placebo control groups. Friedman test is used for intra-group comparison and Kruskal-Wallis with Dunn’s multiple pair comparison tests for inter-group comparison.

a- P<0.05 significant w.r.t. test day 0, b-P<0.01 very significant w.r.t. test day 0, c-P<0.05 significant w.r.t. test day 4, d-P<0.01 very significant w.r.t. placebo day 0, e-P<0.01 very significant w.r.t. placebo day 4, f-P<0.05 significant w.r.t. placebo day 8.

0

0.5

1

1.5

2

2.5

3

0th day4th day

8th day15th day

Test Group Placebo control Group

Graph-15: Effect on Sneezing


82

Table- 16: Effect of drug on Nasal congestion (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days


Test Group

1.76±0.19 2{0,3}

0.86±0.18 1{0,3} a

0.26±0.11 0{0,2}c, d

0.1±0.07 0{0,2} b, e,


1.4±0.31 1.5{0,3}

1.4±0.34 1{0,3}

1.1±0.23 1{0,2}

0.7±0.21 1{0,2}

n= 30 in test and 10 in placebo control groups. Friedman test is used for intra-group comparison and Kruskal-Wallis test with Dunn’s multiple pair comparison tests for inter-group comparison.

a- P<0.05 significant w.r.t. test day 0, b- P<0.05 significant w.r.t. test day 4, c- P<0.01 very significant w.r.t. placebo day 4, d- P<0.05 significant w.r.t. placebo day 8, e- P<0.05 significant w.r.t. placebo day 15.

0

0.5

1

1.5

2

2.5

3


Test Group


Graph-16: Effect on Nasal congestion


83

Table- 17: Effect of drugs on Itchy nose (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days


Test Group

0.6±0.12 1{0,2}

0.3±0.09 0{0,2}

0.1±0.05 0{0,1} a

0.03±0.03 0{0,1} a, b


0.7±0.21 1{0,2}

0.6±0.22 0.5{0,2}

0.5±0.16 0.5{0,1}

0.4±0.16 0{0,1}

n= 30 in test and 10 in placebo control groups. Friedman test is used for intra-group comparison and Kruskal-Wallis with Dunn’s multiple comparison pair tests for inter-group comparison.

a- P<0.01 very significant w.r.t. test day 0, b- P<0.05 significant w.r.t placebo day 0.

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

oth day 4th day 8th day 15th day

Test Group


Graph- 17: Effect on Itchy nose


84

Table- 18: Effect of drugs on Itchy mouth or throat (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days


Test Group

0.6±0.11 1{0,2}

0.36±0.089 0{0,1}

0.2±0.07 0{0,1} a

0.03±0.03 0{0,1}


0.4±0.16 0{0,1}

0.2±0.13 0{0,1}

0.3±0.15 0{0,1}

0.3±0.15 0{0,1}

n= 30 in test and 10 in placebo control groups. Friedman test is used for intra-group comparison and Kruskal-Wallis test with Dunn’s multiple comparison pair tests for inter-group comparison.

a- P<0.05 significant w.r.t. test day 0.

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

oth day 4th day 8th day 15th day

Test Group


Graph- 18: Effect on Itchy mouth or throat


85

Table- 19: Effect of drugs on Lacrimation (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days


Test Group

0.93±0.14 1{0,3}

0.36±0.10 0{0,2} a

0.23±0.07 0{0,1}

0.03±0.03 0{0,1}


0.6±0.16 1{0,1}

0.5±0.22 0{0,2}

0.5±0.16 0.5{0,1}

0.5±0.16 0.5{0,1}


a- P<0.05 significant w.r.t. test day 0.

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1


Test Group

Placebo Contro Group

Graph-19: Effect on Lacrimation


86

Table 20: Effect of drugs on Post nasal drip (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days


Test Group

0.66±0.15 0.5{0,3}

0.26±0.09 0{0,2}

0.10±0.05 0{0,1}

0±0.00 0{0,0} a, b, c


1.00±0.36 1{0,3}

0.70±0.30 0.5{0,3}

0.80±0.29 1{0,3}

0.60±0.31 0{0,3}


a- P<0.01 very significant w.r.t. test day 0, b- P<0.05 significant w.r.t. placebo day 0, c- P<0.05 significant w.r.t. placebo day 8.

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1


Test Group


Graph-20: Effect on Post nasal drip


87

Table-21: Effect of drugs on Headache (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Assessment days


Test Group

0.73±0.14 1{0,2}

0.33±0.12 0{0,3}

0.17±0.08 0{0,2} a

0.13±0.07 0{0,2} a


0.6±0.22 0.5{0,2}

0.5±0.17 0.5{0,1}

0.4±0.16 0{0,1}

0.5±0.22 0{0,2}


a- P<0.01 very significant w.r.t. test day 0

00.10.20.30.40.50.60.70.80.9

1

0th day 4th day 8th day15th day

Test Group


Graph-21: Effect on Headache


88

Table- 22: Effects of drugs on Nasal Smear for Eosinophils (NSFE) (Mean±SEM and Median rating with range in brackets)

n=40

Groups

Nasal Smear for Eosinophils Before treatment After treatment

Test Group

1.73±0.13 2{0,2}

0.03±0.09 a, 0{0,1}


1.00±0.33 1{0,2}

0.8±0.33 0{0,2}

n= 30 in test and 10 in placebo control groups. Kruskal-Wallis test with Dunn’s multiple comparison pair tests are used for inter-group comparison.

a- P<0.001 extremely significant w.r.t. test before treatment,

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

BT AT

Test Group


Graph-22: Effect on NSFE


89

Table-23: Effect of Study on Objective cum Safety parameters (expressed as Mean ± SEM)

n=40

p>0.05, test used Paired‘t’ test

Parameters

Test Group n=30

Placebo Group n=10

BT AT BT AT

Hb (gm %)

14.18±0.36 13.96±0.36 13.47±0.61 13.50±0.51

TLC (Cells/cumm)

8550±295.23

7675±306.81

8080±633.12

7510±518.64

DLC (Cells/cumm)

Polymorphs

60.00±1.78

56.00±1.30

59.00±2.86

61.00±2.04

Lymphocytes

33.0±1.81

38.00±1.34

35.00±2.90

31.00±2.37

Eosinophils

4.00±0.27

4.00±0.19

4.00±0.72

5.00±0.63

Monocytes

2.00±0.18

2.0±0.20

2.00±0.36

2.00±0.45

Basophils

0.06±0.04

0.03±0.03

0±0

0±0

ESR (mm/1hr)

11.86±2.34 12.76±2.38 11.60±5.49 10.60±2.5

Blood Urea (mg/dl)

24.36±1.14 21.76±0.94

24.10±1.47 20.8±1.52

S. Creatinine (mg/dl)

0.86±0.02 0.87±0.03 0.87±0.03 0.89±0.03

SGOT (IU/L)

26.73±1.53 25.80±1.53 22.50±1.08 23.50±1.15

SGPT (IU/L)

32.53±3.28 32.80±2.79 24.00±2.51 24.10±2.91


90

Table-24: Effect of drugs on TSSS (Mean±SEM)

n=40

Group TSSS Before treatment After treatment

Test Group 9.6±0.64 0.90±0.32 a, b, c

Placebo Control

Group 7.80±1.03 5.00±0.94

n=30 in test and 10 in placebo control groups. Paired ‘t’ test is used for intra group comparison and Kruskal-Wallis test with Dunn’s multiple pair comparison tests for inter group comparison.

a- P<0.01 very significant w.r.t. test BT, b- P<0.01 very significant w.r.t. placebo BT, c- P<0.05 significant w.r.t. placebo AT.

0

1

2

3

4

5

6

7

8

9

10

BT AT

9.6

0.9

7.8

5Test Group


Graph-24: Effect of drugs on TSSS


91

Table-25

Overall Effect on the study Based on TSSS and NSFE

n=40

Groups

Sample

Size

Before Treatment After Treatment

NSFE

(+)

NSFE

(-)

TSSS

(Mean)

NSFE

(+)

NSFE

(-)

TSSS

(Mean)

Test Group

30

26

4

9.6

1*

4

0.9

Placebo

Control

Group

10

5

5

7.8

5

5

5.0

Total

40

31

9

17.4

5

9

5.9

* Significantly reduced in numbers.


92

Table-26

Overall Effect on the Study in terms of Response

Effect Test Group Placebo Response in Toto

Cure 28 00 28*

Not Cure 02 10 12

Total 30 10 40

*Fisher’s exact test 2 tailed P<0.001

0

5

10

15

20

25

30

Cure Not Cure

28

20

10

Test Group


Graph-26: Overall Effect of Study


93

Table- 27

Baseline characteristics of the research sample

n=40

Groups Characteristics

Test Group (n=30)

Placebo Control Group (n=10)

Age

29.60±3.39

29.86±1.83

Gender- Male Female

19

11

6

4

Haematological Value

Hb (gm %)

14.18±0.36 13.47±0.60

TLC (Cells/Cumm)

8550.00±295.23 8080.00±633.12

DLC (%): Polymorphs Lymphocytes Eosinophils Monocytes Basophils

60.00±1.784

33.00±1.81

4.00±0.27

2.00±0.18

0.0666±0.05

59.00±2.86

35.00±2.90

4.00±0.72

2.00±0.36

0.000±0.00

ESR (mm/1hr) 11.86±2.34 11.60±5.49 NSFE

1.73±0.13 1.00±0.33

Blood Urea (mg/dl)

24.36±1.14 24.10±1.47

S. Creatinine (mg/dl)

0.86±0.02 0.87±0.03

SGOT (IU/L)

26.73±1.53 22.50±1.08

SGPT (IU/L)

32.53±3.28 24.00±2.51

P>0.05, test used unpaired ‘t’ test for each parameter.

DISCUSSION

Discussion

94

DISCUSSION

The present study was a randomized single blind placebo control clinical trial,

designed to evaluate the safety and efficacy of a Unani formulation in the treatment of

Nazla Haar on scientific basis and modern parameters. This study was conducted at

National Institute of Unani Medicine Hospital, Bangalore over a period of 9 months

from March 2011 to December 2011. A total of 55 patients were registered for

screening, out of which 15 patients did not fulfill the inclusion criteria hence excluded

from the study, and remaining 40 patients completed the course of treatment, out of

which 30 allocated to test and 10 to placebo control groups.

Test group patients were given Unani formulation, which consists of Behidana,

Unnab, and Sapistan in the form of Joshanda along with Sharbate Banafsha 25ml

orally twice a day for 15 days while, placebo control group was treated by caramel

syrup with the same quantity and duration. The severity of subjective parameters

rhinorrhoea, sneezing, nasal congestion, itchy nose, itchy mouth or throat,

lacrimation, post nasal drip and headache were rated on 4 point scale (0-absent, 1-

mild, 2-moderate and 3- severe). These scores were summed in each patient at

assessment point on 0th, 4th, 8th and 15th day to obtain a Total Symptom Severity Score

(TSSS), and the objective parameter NSFE was assessed before and after treatment.

The observations recorded from the trial have been depicted in tables and graphs. The

discussion on the data showing efficacy of the treatment on various subjective and

objective parameters along with demographic data is being presented below in order

to draw inference and to arrive at a conclusion.

In this study a maximum of 37.5% patients were observed in age group of 21-30 years

followed by 25% in age group 31-40 years, 20% patients were observed in 13-20

Discussion

95

years of age and 17.5% in 41-50 years (Table-1 and Graph 1). This study shows a

high incidence of disease in patients between the age of 3rd, 4th and 2nd decade of life.

This study partly exhibit the prevalence of rhinitis is observed in 2nd decade according

to Kumar & Clerk. The mean age of subjects enrolled in the study was found with

29.8 years, which corresponds with the incidence of mean age (29.6 years) from the

study reported by Maiti R et al 112 (2010).

Out of 40 patients enrolled into the study 62.5% i.e., 25 were males and 37.5% i.e., 15

were in females (Table-2 and Graph- 2). Sex wise incidence of the disease as per the

studies of Kurowski M et al 115 (2004) males 79.2%, females 20.8% and Aubier M et

al 116 (2001) 83.0% males and 16.7% females respectively reveal similar evidence.

No credible data is available to demonstrate the existence of this disease among a

particular community in the society. However, this study represents predominance

among Hindu patients with 55% followed by Muslims 42.5% and Christian 2.5%

(Table- 4 and Graph- 4).

Dietary habit was considered on the basis of consuming regularly vegetarian and

non-vegetarian type of diet. Out of 40 patients, 90% were recorded to be of non-

vegetarian and 10% vegetarian (Table- 5 and Graph- 5). This finding is in accordance

with the study by Jan RH and Wen SH 117 (2007) that allergic diseases were less

commonly reported among children consuming a moderate vegetarian diet. As per the

description available in Unani literature, people fond of eating non-vegetarian diet

found to suffer more likely with Nazla Haar. 21

In this study the highest prevalence was observed in middle income group 87.5%,

followed by upper 7.5% and only 5% lower group (Table-6 and Graph-6). These

findings reveal that the middle income group was mostly affected, with least number

Discussion

96

of patients in lower income group; it is evident that this is a disease of affluent with

the reference to Jan RH and Wen SH 117 (2007) and http://www.update.com.

Moreover, this study reflects that more number of patients attending the OPD is from

middle income group.

This study revealed that 60% patients were found to be Balghami and 40% were

Damavi Mizaj (Table 7 and Graph- 7). It is contrary to the description of the cause of

the disease according to Unani system of medicine, although it was defined that

certain factors such as extrinsic and intrinsic will play a role in the cause of the

disease, irrespective of individuals own temperament.

Though this study represents only 30% of positive family history and 70% with

negative (Table- 8 and Graph-8). This observation correspond with the study of

Lundback B 44 (1998) two to six fold for developing rhinitis over adults without a

family history. But according to Dhingra, the chances of children developing allergy

are 20% and 47% respectively, if one or both parents suffer from allergic diathesis. 25

This study revealed occupation of the patients as 25% students, 17.5% each in house

wives and businessmen, 12.5% others, 10% each in teachers and tailors, and 7.5%

mechanics. This study finding is in accordance with the study of Gelis N et al 118

(2007) house wives, public services employees and private employees appear to be

allergic in significantly higher percentage than others (Table- 9 and Graph-9).

This study reported a maximum of 40% patients had 2- 4 years of duration of illness,

followed by 30% with 3 months to 1 year, 15% with 5-7years, 10% with 8-10 years

and 2.5% with 11-16 years of duration (Table 10 and Graph-10). This indicates that

the disease is chronic and resilient in nature and progress slowly. This observation is

in accordance with the findings observed by Kurowski M et al 115 (2004) rhinitis

Discussion

97

symptoms for 2 or more years , Majani G et al 119 (2001) more than 2 years of disease

and Aubier M et al 116 (2001) 2 years or more of duration of symptoms.

Out of 40 patients studied, 55% were found suffering from seasonal allergic rhinitis

and 45% from perennial allergic rhinitis (Table 12 and Graph- 12). This finding is in

consonance with the observation of the study conducted by Alyasin S and Amin R 120

(2007) i.e., 52% seasonal, and 48% perennial along with other mixed types.

Among 40 patients, 42.5% were found allergic to dust and cold, 35% allergic to dust

alone, 12.5% were allergic to dust and smoke, and 10% allergic to others (Table 13

and Graph-13).

Effect of study on subjective parameters

The effect of study on various subjective parameters such as Rhinorrhoea,

Sneezing, Nasal congestion, Itchy nose, Itchy mouth or throat, Lacrimation,

Post nasal drip and Headache were assessed on 0th , 4th , 8 t h and 15th day, and

evaluated on the basis of TSSS an arbitrary grading score scale for severity ranges

from 0 to 3.

Effect on rhinorrhoea:

In test group the median score with range were observed as 2.5 [0, 3], 1[0, 3], 0[0,3],

and 0[0,3] respectively. When intra group comparison was made, it was found that

the test drug reduced the severity of rhinorrhoea, very significantly with p<0.01,

this reduction was found on 8th day when compared with median score of 0th day. In

placebo control group the median score with range were observed as 1 [1, 3], 1[0, 3],

1[1,3], and 1 [0, 2] respectively. Intra group comparison revealed that there was no

significant reduction in rhinorrhoea severity till 15th day when compared with 0th

day.

Discussion

98

When median score of the both groups test and placebo were compared with each

other, it was found that there was significant (p<0.05) and very significant (p<0.001)

reduction in severity of rhinorrhoea on 15th day of test with respect to 0th day and 8th

day placebo respectively (Table 14 and Graph-14). This result indicated that the test

drug is effective in reducing rhinorrhoea. This improvement might be due to the

Qabiz action of Behidana and Lazoojat of Banafsha. These results were claimed and

documented by Najmul Ghani. 67

Effect on sneezing:

In test group the median score with range were observed as 3 [0, 3], 1[0, 3], 0[0,3],


the test drug reduced the severity of sneezing, significantly with p<0.05, this

reduction was found on 4th day when compared with median score of 0th day. In

placebo control group the median score with range were observed as 1.5 [0, 3], 1.5[0,

3], 1[0, 3], and 1 [0, 3] respectively. Intra group comparison revealed that there was

no significant reduction in sneezing severity till 15th day when compared with 0th

day.


other, it was found that there was very significant (p<0.01) reduction in severity of

sneezing on 15th day with respect to 4th day placebo (Table 15 and Graph- 15). The

results showed that the test drug is effective in controlling sneezing. This effect may

be due to anti-allergic property of Behidana and Unnab, which is in conformity with

the properties of the drugs described by Khare CP, Baar EW et al and Su et al.76, 86, 92

Discussion

99

Effect on nasal congestion

In test group the median score with range were observed as 2[0, 3], 1[0, 3], 0[0,2],


the test drug reduced the severity of nasal congestion, significantly with p<0.05, this


placebo control group the median score with range were observed as 1.5 [0, 3], 1[0,

3], 1[0, 2], and 1 [0, 2] respectively. Intra group comparison revealed that there was

no significant reduction in nasal congestion severity till 15th day when compared

with 0th day.


other, it was found that there was very significant (p<0.01) reduction in severity of

nasal congestion on 8th day with respect to 4th day placebo (Table 16 and Graph-16).

The present study revealed that the test drug is effective in relieving nasal

congestion. The improvement might be due to Mulattif action of Behidana, Unnab,

Sapistan and Banafsha; muhallil of Banafsha. These functions are in accordance

with the description given by Najmul Ghani, Kabeeruddin and Anonymous. 67, 69, 70,

72, 85

Effect on itchy nose



the test drug reduced the severity of itchy nose, very significantly with p<0.01, this


placebo control group the median score with range were observed as 1 [0, 2], 0.5 [0,

2], 0.5 [0, 1], and 0 [0, 1] respectively. Intra group comparison revealed that there

Discussion

100

was no significant reduction in itchy nose severity till 15th day when compared with

0th day.


other, it was found that there was significant (p<0.05) reduction in severity of itchy

nose on 15th day with respect to 0th day placebo (Table 17 and Figure 17). This

study exposed that the test drug is useful in reducing itchy nose. The effect may be

due to Musakkine hararat and Mufarrih properties of Behidana; Musaffie khoon and

Ta’deeluddam actions of Unnab; Muaddile safra and Murattib of Banafsha. The

above mentioned drugs are in accordance with the description given by Ibn Rushd,

Najmul Ghani, Kabeeruddin, Hakeem MAH and Anonymous. 8, 67, 69, 70, 81, 84

Effect on itchy mouth or throat

In test group the median score with range were observed as 1 [0, 2], 0 [0, 1], 0[0, 1],

and 0[0, 1] respectively. When intra group comparison was made, it was found that

the test drug reduced the severity of itchy mouth or throat, significantly with

p<0.05, this reduction was found on 8th day when compared with median score of 0th

day. In placebo control group the median score with range were observed as 0 [0,1],

0[0, 1], 0[0, 1], and 0 [0, 1] respectively. Intra group comparison revealed that there

was no significant reduction in itchy mouth or throat severity till 15th day when

compared with 0th day.


other, it was found that there was no significant reduction in severity of itchy mouth

or throat with respect to placebo (Table 18 and Graph-18). It was observed that the

test drug has the property to control itchy mouth or throat, which may be due to

Musakkine hararat and Mufarrih actions of Behidana; ta’deeluddam prosperity of

Discussion

101

Unnab; Muaddile safra and Murattib actions of Banafsha. These findings of above

mentioned drugs are in accordance with the description given by Ibn Rushd, Najmul

Ghani, Kabeeruddin, Hakeem MAH and Anonymous. 8, 69, 67, 70, 81, 84

Effect on lacrimation



the test drug reduced the severity of lacrimation, significantly with p<0.05, this


placebo control group the median score with range were observed as 1 [0, 1], 0[0, 2],

0.5 [0, 1], and 0.5 [0, 1] respectively. Intra group comparison revealed that there

was no significant reduction in lacrimation severity till 15th day when compared with

0th day.


other, it was found that there was no significant reduction in severity of lacrimation

with respect to placebo control (Table 19 and Graph-19). The result revealed that

the test drug was effective in alleviating the symptom lacrimation, which may be due

to the properties of Musakkine hararat, Qabiz and Mufarrih of Behidana; Lazoojat

of Banafsha. These results coincide with the findings documented by Najmul Ghani,

Kabeeruddin and Anonymous. 67, 69, 70, 81

Effect on post nasal drip

In test group the median score with range were observed as 0.5 [0, 3], 0[0, 2], 0[0,1]


the test drug reduced the severity of post nasal drip, very significantly with p<0.01,

this reduction was found on 15th day when compared with median score of 0th day.

Discussion

102

In placebo control group the median score with range were observed as 1 [0, 3], 0.5

[0, 3], 1[0,3], and 0 [0, 3] respectively. Intra group comparison revealed that there

was no significant reduction in post nasal drip severity till 15th day when compared

with 0th day.


other, it was found that there was significant (p<0.05) reduction in severity of post

nasal drip on 15th day with respect to 0th day of placebo (Table 20 and Graph-20).

The result evidence that the test drug was effective in reducing the symptom post

nasal drip, which might be due to Dafe nazla property of Behidana. This result is in

accordance with the properties of the drugs suggested by Anonymous. 69, 70

Effect on headache

In test group the median score with range were observed as 1 [0, 2], 0[0, 3], 0[0, 2]

and 0[0, 2] respectively. When intra group comparison was made, it was found that

the test drug reduced the severity of headache, very significantly with p<0.01, this


placebo control group the median score with range were observed as 0.5 [0, 2], 0.5 [0,

1], 0[0, 1] and 0 [0, 2] respectively. Intra group comparison revealed that there was

no significant reduction in headache severity till 15th day when compared with 0th

day.


other, it was found that there was no significant reduction in severity of headache

with respect to placebo (Table 21 and Graph-21). It was observed that the test drug

was more effective in alleviating the symptom headache. This improvement might

be due to Musakkin action of Unnab and Sapistan; Mulayyane akhlate raqeeqa of

Discussion

103

Unnab; Muhallile warm and Munawwim of Banafsha. These findings of above

mentioned drugs are in accordance with the description given by Ibn Rushd, Najmul

Ghani, Kabeeruddin, Hakeem MAH and Anonymous. 8, 67, 69, 70, 81, 84, 94

The overall improvement in the disease reflected in the form of regression of

various symptoms may be due to the t emperament and different pharmacological

effects of the drugs like Dafe nazla, Muzliq, Mufarrih, Mulattif, Musakkine hararat,

Qabiz, Mufattih, Munzije akhlate ghaleeza, Mulayyane akhlate raqeeqa, Munaffise

balgham, Muhallile warm, Muaddile safra, Ta’deeluddam, Lazoojat, and Murattib

wa munawwim of various ingredients of test formulation which contain Behidana,

Unnab, Sapistan and Banafsha. The beneficial effect of test formulation is

corroborated by the use of these drugs in a variety of respiratory diseases by Unani

scholars is in consonance with the pharmacological actions of drugs described in

Unani literature. Certain experimental studies have shown that Behidana (Cydonia

oblonga) has an inhibitory effect on broad range of the late phase immune reactions

of mast cells, 87 Unnab (Zizyphus jujuba) possesses anti allergic and anti-

inflammatory properties, 92, 99 Sapistan (Cordia dichotoma) has analgesic, anti-

inflammatory, expectorant and hepatoprotective properties, 101-103 similarly the

aqueous extract of Banafsha (Viola odorata) has anti-inflammatory property equal to

corticosteroids in the treatment of inflammatory conditions of the lung. 107

Effect on NSFE

Out of 30 only 26 patients in test and 5 out of 10 in placebo control groups were

positive with nasal smear for eosinophils (NSFE) on baseline day of before

treatment. After the completion of treatment i.e., day 15th, in test group, 1 patient’s

NSFE was found still positive with reduction in number in comparison to baseline,

Discussion

104

and in control group all 5 patients’ were remained. On statistical analysis by

Kruskal-Wallis with Dunn’s Multiple Comparison Pair tests, t he test group

exhibited highly significant (p<0.001) effect on NSFE after the treatment

when compared with baseline before treatment, whereas in placebo control group

no significant changes in NSFE was observed (Table-22 and Graph-22).

Before Treatment After Treatment eosinophil not seen

eosinophil

CR. No. 6320- Nasal smear with Giemsa stain (10 x )

Before TreatmentAfter Treatment

eosinophils not seen

eosinophil

eosinophil

eosinophil

CR. No. 10312-Nasal smear with Giemsa stain (10 x)

Discussion

105

Overall effect on Study

The overall effect of the study is determined based on the TSSS of Mean ± SEM of

subjective parameters. The TSSS in test group before treatment was 9.60 ±0.64 and

0.90±0.32 after treatment, whilst it was 7.80±1.03 and 5.00±0.94 respectively in

placebo control group. When the Mean ± SEM of TSSS in both groups were

compared statistically by using Paired‘t’ test for intra group, and Kruskal–Wallis

with post Dunn’s Multiple Comparison tests for intergroup. It was observed that the

test group was found very significant with p value <0.01 after the treatment when

compared with placebo control and test before treatment (Table-24 and Graph-24).

Moreover, the effect of the study determined in terms of CURE and NOT CURE is

based on the difference of TSSS individual subjective symptoms score along with the

effect on NSFE before treatment was compared with after treatment (Table-25), those

found to be between 0 - ≤ 2 with negative or significant reduction in the number of

NSFE is considered as “cure” , whereas, any change of TSSS with > 2 or remain

unchanged along with no significant reduction or presence of eosinophils is

considered as “not cure”.

In test group out of 30 patients 28 (93.33%) were found < 2 TSSS along with negative

eosinophils, whilst, the placebo group patients were remained positive eosinophils

along with marginal reduction in TSSS without significant change in eosinophils

(Table-25). When the efficacy of both groups in terms of Cure and Not cure was

compared statistically employing Fisher’s Exact test-2 tailed, it was observed that test

drug was highly significant (p<0.001) in comparison to placebo group (Table-26 and

Graph-26).

Discussion

106

Safety evaluation of the Drugs

In order to determine safety of the test drug, parameters like Haemogram, ESR, LFT

and RFT were carried out at base line and at the end of the treatment. The data were

analyzed by using Paired‘t’ test. There was no significant difference observed

(p>0.05) between pre and post treatment for each safety parameters (Table-23).

Hence, it is suggested that the formulation can be used safely at the prescribed

therapeutic dose.

CONCLUSION

Conclusion

107

CONCLUSION

Nazla Haar is a common disease distributed worldwide with prevalence rate that

varies from 2% to 20%. Recently WHO has estimated that 400 million people in the

world suffer from allergic rhinitis. Incidence rates in Asia-Pacific are estimated to be

as high as 48% and rising as societies become more urbanized and adopt western

lifestyles. The symptoms of the disease may improve with advancing age, but the

disease is chronic in nature and complete remission is uncommon, emphasizing the

importance of considering the disorder at all stages of life. It is a major airway

disease, which causes morbidity and significantly impairs patients’ quality of life. It is

also associated with conditions like asthma, sinusitis, nasal polyps, and lower airway

infection.

The present study entitled “Efficacy of a Unani formulation in Nazla Haar” was

conducted at National Institute of Unani Medicine Hospital, Bangalore, in 40

patients with two groups; test and placebo control. Test group was given a Joshanda

of Unani formulation (Behidana, Unnab and Sapistan) along with Sharbate Banafsha

and the placebo control group caramel syrup 25 ml twice a day for 15 days.

The pre and post treatment data from both groups were compared, test group has

shown statistically significant reduction with p<0.01 in the severity of subjective

parameters, while in placebo control group, remained insignificant till 15th day of

treatment. The objective parameter NSFE was found extremely significant (p<0.001)

in test group in comparison to placebo group.

This study reveals that the disease is more common among the younger age group of

people with phlegmatic humour, and socioeconomically middle income category.

Conclusion

108

Majority of the subjects were suffered from seasonal state of Nazla Haar was due to

exposure to either dust, or dust and smoke. Moreover, this study has shown no

clinically significant adverse effects, and overall compliance to the treatment was

commendable. On the basis of results and observation, it can be concluded that the

test drug is effective and safe as a treatment for Nazla Haar.

However, due to the available resources and constrains this study was conducted with

limited parameters, to make the study more comprehensive it could be conducted in

large sample size on various parameters.

SUMMARY

Summary

109

SUMMARY

A randomized single blind placebo controlled clinical study entitled “Efficacy of a

Unani Formulation in Nazla Haar” was conducted after enrolling the patients from

OPD of National Institute of Unani Medicine hospital, Bangalore, after the approval

of the NIUM, Institutional Ethical Committee for Biomedical research during March

2011 to December 2011.

Patients fulfilling the inclusion criterion were subjected to haematological,

biochemical and radiological investigations for obligatory terms of inclusion criteria,

and then enrolled in the study after obtaining a voluntary written informed consent,

then randomized in to two groups test (n=30) and placebo control (n=10); test group

was given a decoction of Behidana, Unnab and Sapistan with Sharbate Banafsha,

placebo group was served caramel syrup 25ml twice a day for 15 days in both groups

respectively. The efficacy of the study was assessed in both groups in terms of

subjective and objective parameters in three follow ups i.e., 4th, 8th and 15th day, based

on the severity of disease and the effect of the treatment on four point scale (0-

absent; 1- mild; 2- moderate; 3- severe). Overall response of study in both groups

was evaluated o n Total Symptom Severity Score (TSSS). The clinical improvement

was recorded on the CRF specifically designed for the study.

After the completion of study, the pre and post treatment data from both groups were

compared, test group has shown significant reduction (P<0.01) in the severity of

subjective parameters like rhinorrhoea, sneezing, nasal congestion, itchy nose, mouth

or throat, lacrimation, post nasal drip and headache, whereas in placebo control group

there was no significant reduction till 15th day of treatment. The objective parameters

especially, NSFE was observed and analyzed in both groups before and after

Summary

110

treatment, by using Kruskal-Wallis with Dunn’s Multiple Comparison Pair tests, the

test group after treatment effects exhibited highly significant (P<0.001) in

comparison of baseline before treatment, whereas, placebo control group has shown

no significant changes.

Moreover, this study has shown no significant adverse effects were observed during

the course of treatment in the test group, and overall compliance to the treatment was

commendable.

Age:

The mean age of the subjects was 29.8 years. The maximum of 35 (62.5%)

patients were found between 21-40 years. This data suggests that the disease is

more prevalent in young adulthood.

Sex:

Male constituted 62.5% and female 37.5%.

Marital status:

65% patients were married and 35% were unmarried in both test and control groups.

Religion:

55% patients were Hindu followed by 42.5% Muslims and 2.5% was Christian.

Dietary habit:

90% patients were non-vegetarian and only 10% were vegetarian.

Socioeconomic status:

Majority of the subjects 87.5% were belonged to middle income category,

followed by upper 7.5% and lower 5%.

Summary

111

Mizaj:

The highest number of subjects was found with Balghami 60% followed by 40%

Damavi temperament.

Family history:

Positive family history was present only in 30% patients and 70% were negative.

Occupation:

The highest incidence of 25% was observed in students followed by 17.5% each in

house wives and businessmen, and 10% each in teachers and tailors.

Duration of illness:

The maximum numbers of patients 40% were found with 2-4 years of duration of

illness followed by 30% with 3 months to 1 year.

Effect of Study on Subjective Parameters

Effect on rhinorrhoea:

Statistically ve r y significant reduction (P<0.01) was observed on 8th day of the

treatment when compared with median score of 0th day in test group. When median

score of the both groups was compared with each other, it was found that there was

significant (P<0.05) and extremely significant (P<0.001) reductions in severity of

rhinorrhoea on 15th day of test, with respect to 0th day and 8th day placebo

respectively.

Summary

112

Effect on sneezing:

Statistically significant reduct ion (P<0.05) was found on 4th day of the treatment

when compared with median score of 0th day in test group. When median score of

the both groups was compared with each other, it was found that there was a very

significant (P<0.01) reduction in severity of sneezing on 15th day of test with respect

to 4th day placebo.

Effect on nasal congestion:

Statistically significant reduction (P<0.05) was found on 4th day of the treatment

when compared with median score of 0th day test group. When median score of the

both groups placebo and test drug were compared with each other, it was found that

there was significant (P<0.05) reduction in severity of nasal congestion on 8th day

with respect to 4th day placebo.

Effect on itchy nose:

Statistically very significant reduction (P<0.01) was found on 8th day of the



significant (P<0.05) reduction in severity of itchy nose on 15th day with respect to 0th

day placebo.

Effect on itchy mouth or throat:

Statistically significant reduction (p<0.05) was found on 8th day of the treatment

when compared with median score of 0th day in test group. When median score of

the both groups was compared with each other, it was found that there was no

significant (P>0.05) reduction in severity of itchy mouth or throat with respect to

placebo.

Summary

113

Effect on lacrimation:

Statistically significant reduction (p<0.05) was found on 4th the day of the



no significant (P>0.05) reduction in severity of lacrimation with respect to placebo.

Effect on post nasal drip:

Statistically very significant reduction (p<0.01) was found on 15th day of the



significant (P<0.05) reduction in severity of post nasal drip on 15th day with respect

to 0th day placebo.

Effect on headache:

Statistically very significant reduction (p<0.01) was found on 8th day of the



no significant (P>0.05) reduction in severity of headache with respect to placebo.

Effect on NSFE

26 patients in test and 5 patients in placebo control groups were positive for NSFE

before treatment on baseline. After the completion of treatment, 1 patient in test

(though reveals positive NSFE, but significant reduction in number of eosinophils)

and all 5 patients in control groups were found positive on. On statistical analysis

t h e test group exhibited highly significant (p<0.001) effect on NSFE after

the treatment when compared with baseline before treatment, whereas in placebo

control group has shown no significant changes in NSFE.

Summary

114

Effect on TSSS:

When the Mean ± SEM of TSSS o f subjective parameters in both groups was

compared statistically and observed that the Mean ± SEM scores of TSSS of

test group was found significantly lowered (P <0.01) after the treatment when

compared with Mean ± SEM scores of TSSS of placebo control and test before

treatment. The inference of the results indicates that the test formulation is effective

in reducing TSSS scores of Nazla Haar.

Overall Effect on the study:

The overall effect of the study reveals that the test group was found very significant

with p value <0.01 after the treatment when compared with placebo control and test

before treatment. In test group out of 30 patients 28 were found < 2 TSSS along with

negative eosinophils, while the placebo group revealed marginal reduction in TSSS

without significant change in eosinophils. The total response of the study in terms of

cure and not cure is observed as out of 30 patients in test group 28 (93.33%) were

cured, and 2 (6.67%) were not cured, whereas, placebo group reveals nil result as

denoted not cured.

BIBLIOGRAPHY

Bibliography

115

BIBLIOGRAPHY

1. Ismail Jurjani. Zakheere Khwarizam Shahi. (Urdu translation by Khan HH).

Vol. 2. Part- 6. New Delhi: Idara Kitabush Shifa; 2010: 201-203.

2. Quamri AMH. Ghina Mana Ma Tarjuma Minhajul Ilaj. (Urdu translation by

CCRUM).1st ed. New Delhi: Ministry of Health and Family Welfare; 2008:

121- 127.

3. Tabri R. Firdausul Hikmat. (Urdu translation by Hakeem MA Shah). Faisal

publication; 2002: 178, 179.

4. Majusi A. Kamilus Sana’a. (Urdu translation by Kantoori GH) Vol. 2.

Lucknow: Munshi Naval Kishore; 2010: 357, 483, 484.

5. Ibn Sina. Al Qanoon fit Tibb. (Urdu translation by Kantoori GH). Vol. 1,

Part 4. New Delhi: Idara Kitabul Shifa; 2010: 660, 661.

6. Tabri AM. Al Moalajat Al Buqratia. (Urdu translation by CCRUM). Vol.1.

New Delhi: Ministry of Health and Family Welfare; 1997: 313-317.

7. Ibn Zohar AMAM. Kitab al Taisir Fil Mudawat wat Tadbir. (Urdu

translation by CCRUM). 1st ed. New Delhi: Ministry of Health and Family

Welfare; 1986: 31.

8. Ibne Rushid AWM. Kitab Al Kulliyat. (Urdu translation by CCRUM). 2nd

ed. New Delhi: Ministry of Health and Family Welfare; 1987: 118, 253, 280.

9. Nafeesi. Moalejat Nafeesi (Arabic). Lucknow: Matba Munshi Naval

Kishore; 1324 Hijri: 210-211.

10. Arzani A. Mizanut Tib. New Delhi: Idara kitabush Shifa; 2002: 59

11. Khan MA. Al Akseer. (Urdu Translation by Kabeeruddin M).Vol. 1. New

Delhi: Eijaz Publishing House; 2003:362-373.

12. Arzani A. Tibe Akbar. (Urdu translation by Hussain M). New Delhi: Idara

Bibliography

116

Kitabush Shifa; 2010: 99-102.

13. Azizi MH. Rhazes and the first clinically exact description of hay fever

(seasonal allergic rhinitis). Iran J Med Sci. Vol. 35; 2010 Sep 262, 263.

14. www.allergy.org.au (Cited 2012 February 02)

15. Rimmer SJ. Allergic rhinitis spring into action. Medicine today. 2007 Nov

47-59.

16. Maqbool M. Text book of Ear, Nose and Throat Diseases. 10th ed. P 145,

147, 148, 152-154.

17. http://www.uptodate.com/contents/clinical-manifestations-and-

epidemiology-of -allergic-rhinitis-rhinosinusitis. (Cited 2012 January 18)

18. http://www.biomedcentral.com/1472-6815/11/3 (Cited 2011 October 11)

19. Khan MA. Akseer Azam; Vol. 1. New Delhi: Idara Kitabush Shifa; 2011:

210- 213.

20. Ibn Hubal. Kitabul Mukhtarat Fil Tibb. (Urdu translation by CCRUM). Vol.

III. New Delhi: Ministry of Health & Family Welfare, Govt. of India; 2004:

130-132.

21. Khan A. Haziq. Karachi: Madina Publishing Company; 1983: 73-78.

22. Qarshi MH. Jamiul Hikmat. New Delhi: Idara Kitabush Shifa. 2011: 521-

523.

23. Ulrik CS, Linstow ML, Backer V. Prevalence and Predictors of Rhinitis in

Danish Children and Adolescents. Allergy. Vol. 55. 2000: 1019-1026.

24. Goldman L, Schafer AI. Cecil medicine. 24th ed. New Delhi: Elsevier India

Private Ltd; 2012: 1622- 1628, 2455-57.

25. PL Dhingra, S Dhingra. Diseases of Ear, Nose and Throat. 5th ed. 2010: 153,

155, 168, 169, 180-185.

Bibliography

117

26. Wang DY, Niti M, Smith JD, Yeoh KH, Ng TP. Rhinitis: do diagnostic

criteria affect the prevalence and treatment. Allergy. Vol. 2002 Feb; 57: 150-

154.

27. http://download.videohelp.com/vitualis/med/nasal cavity.htm (Cited 2012

February 28)

28. BD Chaurasia’s. Human Anatomy Regional and Applied Dissection and

Clinical. Head and Neck and Brain. Vo. 3. 4th ed. 2004: 227-231

29. http://intranasal.net/anatomyphysiology/default.htm #Nasal Cavity Function.

(Cited 2012 February 28)

30. http://pathologyoutlines.com/nasal.html # normal histology. (Cited 2012

February 28)

31. Standring S. Gray’s Anatomy. The Anatomical Basis of Clinical Practice. 39th

ed. Churchill Livingston; 2005: 567-574.

32. Ibn Sina. Al Qanoon Fit Tibb (Arabic version). Vol.3. New Delhi: Jamia

Hamdard; 1418 Hijri 243, 244.

33. Quillen DM, Feller DB. Diagnosing rhinitis: Allergic vs Non allergic.

American Family Physician. 2006 May Vol. 73: 1583-1590.

34. Passalacqua G, Canonica GW, Baiardini I. Rhinitis, rhinosinusitis and quality

of life in children. Pediatr Allergy Immunol. 2007: 18 (18): 40-45.

35. Chowdary VS, Vinay kumar EC, Rao JJ, Rao R, Babu KR, Rangamani V. A

study on Serum IgE and Eosinophils in Respiratory Allergy Patients. Indian J

Allergy Asthma Immunol 2003; 17(1): 21-24.

36. Kumar & Clark. Clinical medicine. 6th ed. Elsevier; 2006: 895-899

37. http://www.pollinex.com/professionals/news-events/2011/09/23/allergic-

rhinitis-affects-40-of-children-worldwide-and-prevalence-is-increasing.

Bibliography

118

(Cited 2012 January 18)

38. Allergiesinasiapacific.com/pdfs/ar_backgrounder.pdf. (Cited 2012 March 07)

39. Deem K, Sherris D and Ponikau JU. Management of allergic rhinitis-

implementation of evidence-based guidelines. TOUCH BRIEFINGS 2008:

100-104.

40. Rondon C, Fernandez J, Canto G, Blanca M. Local Allergic Rhinitis: Concept,

Clinical Manifestations and Diagnostic Approach. J Investig Allergol Clin

Immunol 2010. Vol. 20(5): 364-371.

41. Ozdoganoglu T, Songu M. The burden of Allergic Rhinitis and asthma.

Therapeutic Advances in Respiratory Disease. 2012, 6(1): 11-23.

42. McPhee SJ, Lingappa VR, Ganong WF, Lange JD. Pathophysiology of

Disease an Introduction to Clinical medicine. 2nd ed. Chapter 3. 1997: 36, 37.

43. Bhargava KB, Bhargava SK, Shah TM. A Short Textbook of E.N.T. Diseases

for students and Practitioners. 6th ed. Mumbai Usha Publications. 2002: 143,

150, 154, 155.

44. Lundback B. Epidemiology of rhinitis and asthma. Clinical and Experimental

Allergy: Journal of the British Society for Allergy and Clinical Immunology

1998: 3-10.

45. Kausar Chandpuri. Moajizul Qanoon. New Delhi: National Council for

Promotion of Urdu Language; 1998: 283, 284.

46. Tinana AM, Bloebaum RM, Grant JA. Managing Allergic Rhinitis: The Role

of Pharmacotherapy. Drug Benefit Trends. 2009 Nov 9; Vol. 21 PNM.

47. Jilani G. Makhzanul Ilaj; Vol-1; New Delhi: Idara Kitabush Shifa; 2005: 167,

168.

Bibliography

119

48. Jaffri SAH, Siddique MH. Daqaiqul Ilaj (Urdu Translation). Deoband: Vol. 1.

Mukhtar Press; YNM: 245-248.

49. Deraz TE. Immunopathogenesis of allergic rhinitis. Egypt J Pediatr Allergy

Immunol 2010: 8(1): 3-7.

50. Fauci AS, Braunwald E, Kasper DL, Hauser SL, Longo DL, Jameson JL et

a l. Harrison’s Principles of Internal Medicine.17thed. Vol-2. New Delhi:

Mc Graw Hill; 2008: 2069-2070.

51. Angier E, Willington J, Scadding G, Holmes S, Walker S. Management of

Allergic and non-allergic rhinitis: a primary care summary of the BSACI

guideline. Primary Care Respiratory Journal. 2010; 19 (3): 217-222.

52. Navarro A, Colas C, Anton E, Conde J, Davila I, Dordal MT et al.

Epidemiology of Allergic Rhinitis in Allergy Consultations in Spain:

Allerglogica-2005. J Investig Allergol Clin Immunol. 2009; vol.19: 7-13.

53. Boon NA, Cumming AD, John G. Davidson’s Principles & Practice of

Medicine. Part 1. 20th ed. 2007: 729.

54. Jilani G. Makhzanul Hikmat. Vol-2; New Delhi: Eijaz Publishing House;

1996: 338.

55. McPhee SJ, Papadakis MA, Tierney LM. Current medical diagnosis and

treatment. 2008: PNM (Soft Copy).

56. Daniel C, Thomas B, Jonathan C. Manual of allergy and immunology:

Diagnosis and Therapy. 4th ed. Lippincott Williams & Wilkins Publishers.

2002: 28-31.

57. Conner SJ. Evaluation and treatment of the patient with allergic rhinitis. The

Journal of Family Practice. 2002 Oct Vol. 51: 883-890.

Bibliography

120

58. Koga T, Matsuse H, Kohrogi H, Kohno S, Aizawa H. Impact of nasal

condition on self-assessed Disease Control and Treatment Satisfaction in

Patients with Asthma Complicated by Allergic Rhinitis. Allergology

International. 2007; 56: 427-431.

59. Eapen RJ, Ebert CS, Pillsbury HC. Allergic Rhinitis - History and

Presentation. Otolaryngology Clin N Am. 2008: 325-330.

60. Al Anazy FH. The Role of Nasal Allergy in Otitis Media with Effusion.

Bahrain Medical Bulletin. 2011 March Vol.33. PNM.

61. Jauregui I, Mullol J, Davila I, Ferrer M, Bartra J, Cuvillo AD et al. Allergic

Rhinitis and school performance. J Investig Allergol Clin Immunol. Vol. 19;

2009: 32-39.

62. http://www.emedicine.medscape.com/article/134825-overview. (Cited 2012

January 02)

63. Storms W. Allergic Rhinitis- induced nasal congestion: its impact on sleep

quality. Primary Care Respiratory Journal 2008; 17 (1): 7-18.

64. http://www.thirdage.com/hc/c/allergic-rhinitis-prevention. (Cited 2012

January 28)

65. Weiner JM, Abramson MJ, Puy RM. Intranasal corticosteroids versus oral H1

receptor antagonists in allergic rhinitis: systematic review of randomized

controlled trials. BMJ. 1998 December 12; 317(7173): 1624-1629.

66. Kyrmizakis DE, Papadakis CE, Lohuis PJFM, Manolarakis G, Karakostas E,

Amanakis Z. Acute candidiasis of the oro-and hypopharynx as the result of

topical intranasal steroids administration. Rhinology.1999 October 28; 38: 87-

89.

Bibliography

121

67. Ghani N. Khazainul Advia. New Delhi: Idara Kitabul Shifa; 2010: 397, 398,

419, 420, 787, 788, 950, 951.

68. Prajapathi ND, Purohit SS, Sharma AK, Kumar T. A Handbook of Medicinal

Plants. 1st ed. Jodhpur: Agrobios (India); 2009: 167, 184, 185, 540, 541, 553.

69. Anonymous. Standardization of Single Drugs of Unani Medicine. Part II, III.

New Delhi: Central Council for Research in Unani Medicine (CCRUM).

Ministry of Health & Family Welfare, Govt. of India; 1992: 46, 48, 50, 149,

152, 254, 260.

70. Anonymous. The Unani Pharmacopeia of India. Part 1, Vol. II. New Delhi:

Ministry of Health and Family Welfare, Govt. of India. 2007: 27- 28, 41-42.

71. Chatterjee A, Pakrashi SC. The treatise on Indian Medicinal plants. Vol. 2, 3,

4. New Delhi: National Institute of Science Communication and Information

Resources (CSIR); 2010: 10, 11, 163, 164, 212, 213.

72. Anonymous. Medicinal plants in Folklores of Kashmir Himalayas. New Delhi:

CCRUM, Ministry of Health & Family Welfare, Govt. of India. 2001: 96

73. http://www.motherherbs.com/cydonia-oblonga.html. (Cited 2011 November

28)

74. http://www.naturalmedicinalherbs.net/herbs/c/cydonia-oblonga=quince.php.

(Cited 2011 November 28)

75. Anonymous. The useful plants of India. New Delhi: National Institute of

Science Communication and Information Resources (CSIR); 2006: 140, 141,

154, 679, 680, 702.

76. Khare CP. Indian Medicinal plants an illustrated dictionary with 215 pictures

of crude herbs. New Delhi: 2007; 173, 190, 191, 706, 735, 736.

Bibliography

122

77. Prajapathi ND, Kumar U. Agro’s Dictionary of Medicinal Plants. Jodhpur,

Agrobios (India); 2003: 92, 100, 370, 371, 383.

78. Chopra RN, Nayar SL, Chopra IC. Glossary of Indian Medicinal plants. 1sted.

New Delhi: National Institute of Science Communication and Information

Resources (CSIR); 2002:77, 86, 255, 261.

79. Nadkarni KM. Indian Plants and Drugs with their Medical Properties and

Uses. New Delhi: Srishti Book Distributers; 2005: 379, 1038, 1274- 1275,

1316- 1317.

80. Anonymous. The Wealth of India. Vol. II, X, XI. New Delhi: Council of

Scientific and Industrial Research; 2003: 514, 515, 111, 112, 201, 319, 320.

81. Kabiruddin M. Makhzanul Mufradat. New Delhi: Idara Kitabul Shifa; 2007:

116, 117, 118, 251, 295.

82. Evans WC. Treas and Evans Pharmacognosy. 15th ed. London: Saunders

Publishers; 2008: 29, 211, 456, 481.

83. Ibn Sina. Al Qanoon fit Tibb (English Translation) Vol-2. New Delhi:

Jamia Hamdard; 1998: 111, 254, 261, 327, 328.

84. Hakeem Mohd Abdul Hakeeem. Bustanul Mufradat. New Delhi: Idarul

Kitabul Shifa; 2002: 138, 139, 149, 396.

85. Kabeeruddin M. Ilmul Advia Nafeesi. New Delhi: Aijaz Publishing House;

2007: 79, 162, 163, 164, 167, 168.

86. Baars EW and Savelkoul HFJ. Citrus/ Cydonia comp. can restore the

immunological balance in seasonal allergic rhinitis- related immunological

parameters In Vitro. Hindawi Publishing Corporation Mediators of

Inflammation. Vol. 2008, Article ID 496467. 5 PNM.

Bibliography

123

87. Kawahara T and Zuka T. Inhibitory effect of hot-water extract of quince

(Cydonia oblonga) on immunoglobulin E- dependent late-phase immune

reactions of mast cells. Chemistry and Material Science, Cytotechnology. Vol.

63: 143-152.

88. Costa RM, Magalhães AS, Pereira JA, Andrade PB, Valentão P, Carvalho M

et al. Evaluation of free radical-scavenging and anti haemolytic activities of

quince (Cydonia oblonga) leaf: A comparative study with green tea (Camellia

sinensis). Food and Chemical Toxicology 47 (2009) 860-865.

89. Oliveira AP, Pereira JA, Andrade PB, Valentao P, Seabra RM and Silva BM.

Phenolic profile of Cydonia oblonga Miller leaves. J. Agric. Food Chem.

2007, 55, 7926- 7930.

90. Magalhães AS, Silva BM, Pereira JA, Andrade PB, Valentão P, Carvalho M.

Protective effect of quince (Cydonia oblonga Miller) fruit against oxidative

haemolysis of human erythrocytes. Food and Chemical Toxicology 47 (2009)

1372-1377.

91. Kirtikar KR, Basu BD, An ICS. Indian Medicinal Plants with Illustration. Vol.

I, III, VII. 2nd ed. Uttaranchal: Oriental enterprises; 2003: 281, 282, 819, 821,

822, 2310, 2313, 2314.

92. Su, X., Chen, Z., Jiao, B., Huang, Q., Li, W. (2000) Studies on anti-allergic

activity of common food stuffs in China and their constituents. [Chinese]. In,

Vol. 21. Journal of Southwest Agricultural University, 15. PNM.

93. Dymock W, Warden CJH, Hooper D. Pharmacographia Indica- A History of

the Principal Drugs. Vol. I, II. New Delhi: Srishti Book Distributors; 2005:

140-141, 350, 351, 518- 520.

Bibliography

124

94. Anonymous. Contribution of the Unani Medicinal Plants from North Arcot

District-Tamil Nadu, CCRUM. New Delhi: Ministry of Health & Family

Welfare. 1992: 125.

95. Syed HM. Hamdard pharmacopoeia of Eastern Medicine. Delhi: Sri Satguru

Publications; 1997: 12, 19, 30, 31, 36, 45, 66, 171, 176, 248.

96. Ibn Al Baitar. Al Jamiul Mufradatul Advia val Aghzia. (Urdu translation

CCRUM). New Delhi: Ministry of Health & Family Welfare, Govt. of India;

Vol.III. 1999: 23-24, 314, 315.

97. Ibn Al Baitar. Al Jamiul Mufradatul Advia val Aghzia. (Urdu translation

CCRUM). New Delhi: Ministry of Health & Family Welfare, Govt. of India;

Vol. I. 1986: 287-289.

98. http://www.ayurnepal.com/medicinal plants/219-zizyphus jujuba.html. (Cited

2011 June 12)

99. Al-Reza SM, Yoon JI, Kim HJ, Kim JS, Kang SC. Anti-inflammatory activity

of seed essential oil from Zizyphus jujuba. Food and Chemical Toxicology 48

(2010): 639-643.

100. Haleem MA. Mufarradate Azeezia. New Delhi: CCRUM, Dept. of AYUSH,

Ministry of Health & Family Welfare, Govt. of India. 2009: 35, 103.

101. Singh R, Lawania RD, Mishra A, Gupta R. Role of Cordia dichotoma seeds

and leaves extract in degenerative disorders. International journal of

Pharmaceutical Sciences Review and Research. Vol. 2, 2010 May-June: 21-

24.

102. Kuppast IJ and Nayak PV. Wound healing activity of Cordia dichotoma Forst.

F. fruits. Research Article. Vol. 5(2), 2006 March-April: 99-102.

Bibliography

125

103. Sharma US, Sharma UK, Sutar N. Singh A and Shukla DK. Anti-

inflammatory activity of Cordia dichotoma forst f. seeds extracts. International

Journal of Pharmaceuticals Analysis, Vol. 2, 2010: 01-04.

104. Maisale AB, Attimarad SL, Haradagatti DS, Karigar A. Anthelmintic activity

of fruit pulp of Cordia dichotoma. International Journal of Research in

Ayurveda & Pharmacy, 1 (2), 2010 Nov-Dec: 597-600.

105. Kokate Ck, Purohit AP, Gokhale SB. Pharmacognosy. 43rd ed. 2009: 11.54,

11.55

106. Bentley R and Trimen H. Medicinal Plants. Vol. I, III, 1st ed. Delhi: Asiatic

Publishing House; 2002: 133-135, 569- 571.

107. Koochek MH, Pipelzadeh MH, Mardani H. The Effectiveness of Viola

odorata in the Prevention and Treatment of Formalin-Induced Lung Damage

in the Rat. Journal of Herbs, Spices and medical Plants. Vol. 10, 2003: 95-103.

108. Ebrahimzadeh MA, Nabavi SM, Nabavi SF, Bahramian F and Bekhradnia AR.

Antioxidant and free Radical Scavanging Activity of H. Officinalis L. Var.

Angustifolius, V. Odorata, B. Hyrcana and C. Speciosum. Pak. J. Pharm. Sci.,

Vol. 23, NO. 1, 2010 Jan: 29-34.

109. http://medcosmospsm.blogspot.in/. (Cited 2010 January 10)

110. Kabeeruddin A. Bayaze Kabeer. Delhi: Idara Kitabush Shifa; 2010: 13.

111. Anonymous. National Formulary of Unani Medicine. Part I Urdu Edition.

New Delhi: Govt. of India, Ministry of Health & Family Welfare. 1993:334.

112. Maiti R, Rahman J, Jaida J, Allala U, and Palani A. Rupatadine and

Levocetrizine for Seasonal Allergic Rhinitis a Comparative Study of Efficacy

and Safety. Archotolaryngol Head Neck Surg. Vol. 136 (8), 2010 Aug: 796-

800.

Bibliography

126

113. http://www.ncbi.nlm.nih.gov/pubmed/11859651. (Cited 2012 March 09)

114. Rogkakou, Anthi, Villa, Elisa, Garelli, Valentina et al. Persistent Allergic

Rhinitis and the XPERT Study. World Allergy Organization Journal. Vol. 4,

2011 March: 32-36.

115. Kurowski M, Kuna P, and Gorski P. Montelukast plus Cetrizine in the

prophylactic treatment of seasonal allergic rhinitis: influence on clinical

symptoms and nasal allergic inflammation. European Journal of Allergy and

Clinical immunology. Vol. 59, 2004 March: 280-288.

116. Aubier M, Neukirch C, Peiffer C, and Melac M. Effect of Cetrizine on

bronchial hyperresponsiveness in patients with seasonal allergic rhinitis and

asthma. European Journal of Allergy and Clinical immunology. Vol. 56, 2001

Jan: 35-42.

117. Jan RH, and Wen SH. The relationship between vegetarian diets and the

prevalence of Asthma, allergic rhinitis and atopic eczema in Taiwanese school

children. Tzu Chi Med J 2007, 19: 60- 65.

118. Gelis N, Prokopakis E, Helidonis E, and Velegrakis G. Investigation of the

relationship between allergic rhinitis and personality traits using semeiometry.

Hippokratika Quarterly Medical Journal. 2007 Jul-Sep; 11(3): 138-141.

119. Majani G, Biardin I, Giardin A, Senna GE, Minale P, D’ulisee S et al. Health

related quality of life assessment in young adults with seasonal allergic

rhinitis. European Journal of Allergy and Clinical immunology. Vol. 56, 2001

April: 313-317.

120. Alyasin S and Amin R. The Evaluation of New Classification of Allergic

Rhinitis in Patients Referred to a Clinic in the City of Shiraz. Iran J Allergy

Asthma Immunol. 2007 March; 6(1): 27-31.

ANNEXURES

Annexure

127

Annexure-I

“Efficacy of a Unani formulation in Nazla Haar” National Institute of Unani medicine

Case Record Form

S. NO: ……………….. OPD/ IPD NO: …………..……CR NO:..………………. Name:…………….…….................................. Age/Sex: ……………………… Father / Husband’s / Guardian name:………….….……………………………….. Religion: ……………………………… Marital status: ………………… Occupation:................................................................. Present Address with telephone number:…………………………………………. ……………………………………………………………………………………….. ………………………………………………………………………………………. ……………………………………………………………………………………… Group Allocated: Test:……………………….. Control:…………………………………… Date of starting of treatment: ……........................ ……………………………….. Date of completion of treatment: ……………………... …………………………. Chief Complaints with duration:

No Features 0 1 2 3 Since 1 Running nose 2 Sneezing 3 Nasal congestion 4 Itchy nose, 5 Itchy mouth or throat 6 Itchy eyes/ lacrimation 7 PND 8 Headache

H/O Present illness: ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..……………………………..…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………....

Annexure

128

Family history: Father.................................................. Mother………………………… Brother................................................ Sister………………………….. Son/s…………………………….. Daughter/s……………………. Personal history: 1. Appetite: Good / Fair/Poor. 2. Thirst: excess/moderate 3. Diet:Veg. /Non Veg /Mixed 4. Bowel habit: regular/constipated/loose stool 5. Bladder: normal/abnormal 6. Sleep: sound/disturbed/normal 7. Swimming: occasional 8. Psychological status: ………. 9. Learning ability: 10. Productivity at work or school: Habits: Snuffs: occasional/moderate/heavy/nil Tobacco/betel chewing: occasional/moderate/heavy/nil Alcohol: occasional/moderate/heavy/nil Smoking: occasional/moderate/heavy/nil Allergy: Dust/Cold/Smoke/Perfumes/Offensive odors/ Others- if any specify:………………… Socio-economic history:

1. Independent 2. Dependent

Upper class/Upper Middle class/Lower Middle Class…………………………………. Upper Lower class/Lower class……………………………………………………… Education…………………………………….…Income…………………………. Occupational history: Name of work ……………………... Nature of work …………………………… Treatment history: Allopathic / Unani / Ayurvedic / Homeopathic……………………………………………

Annexure

129

GENERAL PHYSICAL EXAMINATION 1. Built ……………… …………. 2. Body weight…………………………. 3. Height ............................... 4. Pallor.................................................... 5. Cyanosis Y/N 6. Clubbing of finger Y/N 7. Icterus Y/N 8. Edema Y/N 9. Lymphadenopathy Y/N 10. Mouth breathing Y/N 10. Vital signs: Pulse: …………beats/min. Blood pressure: ……………mmHg Temperature: …………… Respiratory rate:…………breath/min. SYSTEMIC EXAMINATION: 1. Nervous system:

Higher mental functions: …………………………………………………………. Motor functions: …………………………………………………………………. Sensory functions: ……………………………………………………………….. Reflexes: ………………………………………………………………………….

2. Cardiovascular System:

Inspection………………………………………………………………………… Palpation………………………………………………………………………… Percussion………………………………………………………………………… Auscultation………………………………………………………………………

3. Respiratory system:

Inspection………………………………………………………………………… Palpation………………………………………………………………………… Percussion………………………………………………………………................. Auscultation………………………………………………………………………

4. Digestive system:

Inspection………………………………………………………………………… Palpation………………………………………………………………………… Percussion………………………………………………………………................. Auscultation ……………………………………………………………………….

Annexure

130

LOCAL EXAMINATION External examination of nose: Normal/Abnormal Sense of smell: Normal/Abnormal Oral cavity: Tonsils: Normal/ Abnormal Pharynx: Normal/ Congested Nasal mucosa: Rt. / Lt. / Both: Pale/ cyanotic/ swollen with clear secretion Inferior turbinate: Rt. / Lt. / Both: Normal/ Swollen Nasal discharge: Absent/ Lt. / Rt. / both sides: Thin, watery/ mucoid/ Purulent/ mucopurulent Nasal obstruction: Absent/ Lt. / Rt. / both sides Anterior rhynoscopy: Right nostril: Normal/redness/swelling/furunculosis Dislocated anterior end of the septum Left nostril: Normal/redness/swelling/furunculosis Dislocated anterior end of the septum Eyes: Lacrimation: Yes/ No Lids: Upper/ Lower / Both: Normal/ edema: Conjunctivae: Rt. / Lt. / Both: Normal/ Congestion

Subjective Parameters

S. No Clinical Features


1. Running nose

2. Sneezing 3. Nasal discharge

4. Itchy nose

5. Itchy Mouth or throat

6. Itchy Eyes/ lacrimation

7. PND

8. Headache

Annexure

131

Objective Parameters cum Investigations

Safety Parameters

Signature of the PG scholar: ……………………………………………… Signature of the Supervisor: ………………………………………………

S. No. Parameters Before treatment After treatment 01. Hb%

02. TLC 03. DLC: Polymorphs

Lymphocytes Eosinophils Monocytes Basophils

04. ESR

S. No. Parameter Before treatment After treatment 05. Nasal Smear for

Eosinophils (NSFE)

S. No. Parameters Before treatment After treatment

01. Serum Creatinine

02. Blood urea

03. AST

04. ALT

Annexure

132

Annexure-II

Proforma for Assessing Mizaj

Name of the patient with Age & Sex:……………………………..………………. Parameter Damavi Balghami Safravi Sawdavi

Complexion Reddish/wheat brown

1 Chalky/whitish 0.75 Pale/ yellowish

0.5 Blackish 0.25

Body built Muscular & broad

1 Fatty & broad 0.75 Moderate in muscular & thin

0.5 Skeletal 0.25

Touch Hot & soft 1 Cold & soft 0.75 Hot & dry 0.5 Cold & dry

0.25

Hair Blackish 1 Brownish 0.75 Yellowish 0.5 Black & white

0.25

Movement Active 1 Dull 0.75 Hyperactive 0.5 Less active

0.25

Diet most liked

Cold & dry 1 Hot & dry 0.75 Cold & moist

0.5 Hot & moist

0.25

Weather most suitable

Spring 1 Summer 0.75 Winter 0.5 Autumn 0.25

Sleep Normal 1 Excess 0.75 Inadequate 0.5 Insomnia 0.25 Pulse Normal rate

70-80/min 1

Slow 60-70/min normal volume

0.75

Rapid 80-100/min normal volume

0.5

Slow 60-70/min low volume

0.25

Emotions Normal 1 Calm & quiet 0.75 angry 0.5 Nervous 0.25 Total points

Range of Temperament in numbers:

Damavi= 7.51- 10.00

Balghami= 5.10- 7.50

Safravi= 2.51-5.00

Sawdavi= 0.00-2.50

Damvi

Balghami Safravi Sawdavi

Annexure

133

Annexure-III

KUPPUSWAMI'S CLASSIFICATION (Modified for 2008/’09)

Score cord A Education Score

1. Professional Degree , PG and Above 7 2. Graduate 6 3. Intermediate or Past High School Diploma 5 4. High School Certificate 4

5. Middle School Completion 3 6. Primary School or Literate 2 7. Illiterate/ Uneducated 1 B

Occupation Score

1. Profession 10 2. Semi Profession 6 3. Clerk, Shop Owner, Farm Owner 5 4. Skilled Worker/ House wife 4 5. Semi Skilled Worker 3 6. Unskilled 2 7. Unemployed 1 C. PER CAPITA INCOME ( Rs. Per Month )

1. 1500 or above 12 2. 750-1499 10 3. 565-749 6 4. 375-564 4 5. 225-374 3 6. 75-224 2 7. Below 75 1

The Total Score is Graded as follows: Upper 26-29 Upper Middle 16-25 Lower Middle 11-15 Upper Lower 5-10 Lower < 5

Annexure

134

Annexure-IV

Informed Consent Form “Efficacy of a Unani formulation in Nazla Haar” Information to the participants

The main aim of the present study is to evaluate the efficacy of a pharmacopeial

compound formulation, in comparison of placebo, to provide safe, effective and

economic drug for the management of Nazla Haar. Various forms of medicinal

preparations such as sharbat, laooq, qurs, haboob and joshanda are used in the

treatment of Nazla Haar. The test formulation is a combination of drugs possessing

anti-inflammatory and soothing properties used in the form of Joshanda (decoction)

along with Sharbat (Syrup), and an inert substance (placebo). The total duration of the

study is 15 days. There are no reasonably foreseeable risks or discomforts to you

during the research. The confidentiality of records identifying you will be strictly

maintained and only the research scholar or the guide will have access to your

medical records. All your blood/any sample will be utilized only for research purpose.

You may contact me for trial related queries, and you have rights to clear all your

doubts regarding the treatment or any possible adverse reactions of the treatment. No

anticipated prorated payment shall be made to you for participating in the trial. You

are responsible for all consequences of the treatment, either benefit or harm on

participation in the trial. You have to answer all the pertinent questions asked by the

research scholar regarding your illness.

Undertaking by the Investigator

Your consent to participate in the above mentioned study by A. H. Ayshah Fazeenah,

P.G. Scholar, Dept. of Moalajat, NIUM, Bangalore is sought. You have the right to

refuse consent or withdraw the same during any part of the study without giving any

reason. In such an event, you will continue to receive the treatment as usual. If you

have any doubts about the study, please feel free to clarify the same. Even during the

study, you are free to contact the investigators for clarification if you desire. All the

information / data collected from you will be kept in strict confidence.

Annexure

135

Efficacy of a Unani formulation in

Nazla Haar

Patient Consent Form

OPD/IPD No:……………………. Date:……………………

I ………………………………………………….exercising my free power of choice,

hereby give my consent to be included as a subject in the clinical trial for the

treatment of Nazla Haar. I understand that I may be treated with these drugs for the

disease; I am suffering from Nazla Haar. I have been informed to my satisfaction, by

attending physician the purpose of the clinical trial and the nature of drug treatment

and follow up including the laboratory investigations to monitor and safeguard my

body function.

I am also aware of my right to opt out of the trial at any time during the course of the

trial without having to give the reason for doing so.

………………………… …………………….

Signature of PG Scholar: Signature of the patient

……………………..

Name of Supervisor

Annexure

136

KEY TO MASTER CHART

AT After Treatment

Bal. Balghami

Baso. Basophils

BT Before Treatment

Bus . Business

Chr Christian

CK Cook

Clk Clerk

cm centimeter

co. Cold

C.Op Computer operator

Cpt Carpenter

CR N0. Clinical Record Number

cumm Cubic millimeter

Dam. Damvi

Dl Decileter

DLC Differential Leukocyte Count

Dvr. Driver

du dust

Eosin. Eosinophils

ESR Erythrocyte Sedimentation Rate

F Female

gm gram

Annexure

137

Hb Hemoglobin

Hin. Hindu

hr Hour

Hw House wife

IU/L International unit per liter

Lc Lower class

Lymph. Lymphocytes

M Male

Mc Middle class

Mec. Mechanic

mg/dl milligram per deciliter

Mono. Monocytes

Mus. Muslim

NSFE Nasal Smear For Eosinophils

NV Non vegetarian

Per. Perfume

PND Post Nasal Drip

Poly. Polymorphs

Pr. Perennial

Ofs. Offensive

S. Serum

Sec. Security

SES Socioeconomic status

SGOT Serum Glutamic Oxalo acetic Transaminase

SGPT Serum Glutamic Pyruvate Transaminase

Annexure

138

Smk. Smoke

S. No. Serial Number

Ss. Seasonal

St . Student

T Teacher

Tai. Tailor

TLC Total Leukocyte Count

TSSS Total Symptom Severity Score

Uc Upper class

UM Unmarried

V. Vegetarian

0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 BT AT

1 6320 19 F Mus UM Mc St Yes No NV 0.5 Ss Dam du. Smk 3 3 1 1 2 1 1 1 2 1 1 0 0 0 0 0 0 0 0 0 1 1 1 0 1 0 0 0 0 0 0 0 9 2

2 7144 36 M Hin M Mc Bus No No NV 5 Ss Bal. du. 2 2 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 4 0

3 7582 15 F Hin UM Mc St Yes No NV 1 Ss Bal. du. smk 2 1 1 0 2 1 1 0 1 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 1 1 0 0 0 0 0 0 7 0

4 8497 23 M Mus UM Mc St Yes No NV 1.5 Ss Bal. du.smk. Per. 3 2 1 0 3 2 3 1 1 1 0 0 0 0 0 0 0 0 0 0 1 2 1 0 3 2 1 1 1 1 0 0 12 1

5 9093 36 F Hin M Uc T Yes No NV 12 Ss Bal. du. Ofs 3 2 1 0 1 1 0 0 2 0 0 0 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 2 1 1 2 11 2

6 3176 35 M Hin M Mc Sec Yes No NV 2 Pr Dam. du. Ofs 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 4 0

7 8959 13 F Mus UM Mc St Yes No NV 0.25 Ss Bal. du.smk. Per. 0 0 0 0 3 2 1 0 2 1 1 0 0 0 0 0 1 1 1 0 1 1 1 0 1 1 1 0 2 1 1 0 10 0

8 8746 48 M Hin M Mc T Yes Yes NV 3 Ss Bal. du. 3 0 0 0 2 0 1 0 3 0 0 0 1 1 0 0 0 0 0 0 3 1 1 1 1 0 0 0 0 0 0 0 13 1

9 10068 39 F Hin M Mc Hw Yes Yes NV 2 Ss Bal. du. Cold 2 1 0 0 3 2 1 1 3 0 0 0 0 0 0 0 0 0 0 0 2 1 0 0 2 1 0 0 2 3 2 1 14 2

10 10312 25 M Mus UM Lc Tai No No NV 2 Pr Dam. du.co.smk 3 3 0 0 3 0 0 0 3 3 0 0 2 1 0 0 2 1 0 0 2 1 0 0 1 1 0 0 0 0 0 0 16 0

11 28067 27 F Mus UM Mc T Yes Yes NV 1 Ss Bal. du. Per. 1 0 1 0 1 0 0 0 3 2 0 0 1 1 0 0 1 1 0 0 1 0 0 0 0 0 0 0 2 1 0 0 10 0

12 11139 42 M Mus M Mc Cpt Yes No NV 4 Pr Bal. du. 2 1 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 1 0 0 0 0 0 0 0 6 0

13 11251 21 F Mus UM Mc Hw Yes No NV 4 Pr Bal. du. Cold 3 0 1 0 3 3 0 0 3 1 0 0 1 0 0 0 0 0 0 0 2 0 0 0 3 2 0 0 1 0 0 0 16 0

14 11287 50 M Hin M Uc T Yes No NV 15 Ss Bal. du. 1 1 0 0 3 3 0 0 1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 6 0

15 11932 25 M Hin UM Mc St Yes No NV 4 Pr Bal. du. Cold 2 1 0 0 2 0 0 0 2 1 0 0 2 2 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 9 0

16 111193 22 M Chr UM Mc St Yes Yes NV 0.25 Ss Bal. du. Cold 1 1 0 0 3 1 0 0 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 0

17 114902 28 M Hin M Mc Tai Yes No NV 1 Pr Bal. du 3 3 3 2 1 1 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 2

18 11049 28 F Mus M Mc Tai Yes No NV 3 Pr Bal. du. 3 2 2 1 3 1 1 0 0 0 0 0 2 1 1 0 2 1 1 0 2 1 1 0 1 0 0 0 1 0 0 0 14 1

19 115473 27 F Mus M Mc Hw Yes No NV 3 Pr Bal. du 3 2 1 1 2 1 1 1 3 3 2 1 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 13 3

20 115621 45 M Hin M Mc mec Yes Yes NV 7 Pr Bal. du. Per. 3 1 0 0 3 1 0 0 3 0 0 0 1 0 0 0 1 0 0 0 1 1 1 0 0 0 0 0 1 0 0 0 13 0

21 115762 46 M Hin M Mc Bus Yes No NV 5 Pr Dam. du 0 0 0 0 3 2 1 0 3 2 1 0 1 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 9 0

22 115249 20 M Hin UM Mc St Yes Yes V 3 Ss Dam. du. Cold 3 1 1 0 3 1 0 0 3 3 0 0 1 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 12 0

23 116645 34 M Hin M Mc Tai Yes No NV 10 Pr Dam. du 3 3 3 3 3 3 3 3 2 2 2 2 1 0 0 0 1 0 0 0 0 0 0 0 1 1 1 0 1 0 0 0 12 8

24 115165 33 M Hin M Mc Dvr Yes No NV 2 Pr Dam. du. Cold 3 3 1 0 2 2 1 0 0 0 0 0 1 1 0 0 1 1 0 0 1 1 0 0 1 1 1 0 1 1 0 0 10 0

25 117313 24 M Mus M Mc Clk Yes No NV 1.5 Ss Bal. du 1 0 0 0 0 0 0 0 2 1 1 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 1 0 0 0 6 0

26 117893 27 M Hin M Mc CK Yes No NV 0.66 Ss Bal. Cold 3 3 1 0 3 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 1 0 0 9 0

27 118616 37 M Hin M Mc Bus Yes Yes NV 10 Ss Dam. du. Cold 2 1 0 0 3 0 0 0 1 0 0 0 1 1 0 0 1 1 0 0 1 0 0 0 1 0 0 0 1 0 0 0 11 0

28 111502 20 F Mus UM Mc St Yes Yes NV 2 Ss Bal. du. Smk 2 1 0 0 3 2 1 0 3 2 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 8 0

29 122410 18 F Mus UM Mc St Yes No NV 4 Ss Bal. du. Cold.Per 0 0 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 1 1 3 2

30 123793 33 M Mus M Mc C.Op Yes Yes NV 5 Pr Dam. du 3 1 0 0 3 3 1 0 0 0 0 0 0 0 0 0 1 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 8 0

MASTER CHART - TEST GROUP

Itch

y m

ou

th

& t

hro

at

Itch

y e

yes

/ la

crim

ati

on

PN

D

Hea

da

che

Du

rati

on

of

illn

ess

(yea

rs)

Sea

son

al

va

riati

on

Miz

aj

All

erg

en

Tre

atm

ent

His

tory

Fa

mil

y h

isto

ry

Die

t Sn

eezi

ng

Na

sal

con

ges

tio

n

Itch

y n

ose

S.N

o

CR

.No

Age

in y

ears

Sex

Rel

igio

n

Ru

nn

y n

ose

Mari

tal

statu

s

Soci

o E

con

om

ic

Sta

te

Occ

up

ati

on

Subjective parameters

TSSS

0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 0 4 8 15 BT AT

1 8809 28 F Hin M Mc Hw Yes No NV 10 Ss Dam. du. 1 1 1 1 0 0 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 4 4

2 10691 23 F Mus M Mc Hw Yes No NV 1 Pr Dam. du, Cold 1 1 1 0 1 1 1 0 2 1 1 0 1 1 1 0 1 0 0 0 1 0 0 0 0 0 0 0 1 1 0 0 8 1

3 11850 20 F Mus M Lc Hw Yes No NV 1 Pr Bal. du. 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 1 1 1 1 3 3 3 3 0 0 0 0 7 7

4 114732 23 M Mus UM Mc mec Yes No NV 0.5 Pr Dam. du. Cold 3 3 3 2 3 3 2 2 2 3 2 1 1 0 1 1 1 0 1 1 1 0 1 1 3 0 1 1 0 0 0 0 14 10

5 115477 33 M Hin M Mc Sl.mn No Yes NV 6 Pr Dam. du.cold 1 1 1 1 3 3 3 3 3 3 2 2 0 0 0 0 0 0 0 0 1 2 1 1 0 0 0 0 0 0 0 0 8 7

6 112444 45 M Mus M Mc Owr Yes No NV 3 Ss Dam. du. 1 1 1 0 2 2 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 1 1 1 1 6 3

7 115433 33 F Hin M Mc Hw Yes No NV 3 Pr Bal. du.cold 2 2 2 0 3 3 2 1 2 2 1 0 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 12 6

8 116088 50 M Hin M Uc Bus Yes Yes V 10 Ss Dam. du. Cold 1 1 2 1 1 1 1 1 2 2 2 1 1 1 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 7 6

9 116087 18 M Hin UM Mc St Yes Yes V 0.25 Ss Dam. du. Cold 1 1 1 1 2 2 2 1 0 0 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 3

10 119065 23 M Hin M Mc Sl.mn Yes No V 1 Ss Bal. du. Cold 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 2 1 1 2 9 9

MASTER CHART- PLACEBO CONTROL GROUP

S.N

o

CR

No

Age

in y

ears

Sex

Rel

igio

n

Mar

ital s

tatu

s

Soci

o E

cono

mic

Sta

te

Itch

y ey

es/ l

acri

mat

ion

Occ

upat

ion

Tre

atm

ent H

isto

ry

Fam

ily h

isto

ry

Die

t

Dur

atio

n of

illn

ess i

n ye

ars

Seas

onal

var

iatio

n

PND

Hea

dach

e

Miz

aj

Alle

rgen

Run

ny n

ose

Snee

zing

Nas

al c

onge

stio

n

Itch

y no

se

Itch

y m

outh

& th

roat

Subjective parameters

TSSS

1 8809 10.9 6100 60 34 5 1 0 2 0 10.9 6100 60 34 5 1 0 2 0 20 0.7 22 14 20 0.7 22 142 10691 10.9 10400 59 34 4 3 0 60 2 11.5 9000 55 37 5 3 0 60 2 23 0.7 26 29 23 0.9 27 233 11850 13.9 9400 74 16 10 0 0 6 0 13.9 9400 74 16 10 0 0 6 0 22 0.9 25 17 22 0.9 25 174 114732 16 9000 63 32 4 1 0 4 0 15.3 7200 62 31 3 4 0 6 0 23 0.9 21 42 25 0.9 27 435 115477 13.6 6100 61 34 3 2 0 5 2 13.6 5600 57 37 3 3 0 8 2 25 0.9 15 21 25 1 20 256 112444 16 10000 51 43 3 3 0 5 2 15.6 10500 60 35 4 1 0 5 2 17 0.9 22 28 23 1.1 24 307 115433 11.7 10800 42 49 6 3 0 15 2 11.7 7500 63 27 6 4 0 21 2 21 0.9 20 22 17 0.9 16 178 116088 13 6400 69 26 2 3 0 7 0 14 6900 70 22 4 4 0 11 0 31 0.9 23 26 11 0.8 28 349 116087 15.3 6400 57 38 4 1 0 4 2 14.7 7200 57 36 5 2 0 3 2 28 1 27 23 16 0.9 24 22

10 119065 13.4 6200 53 41 3 3 0 8 0 13.8 5700 54 39 5 2 0 24 0 31 0.9 24 18 26 0.8 22 16

Objective Parameters

S.N

o

CR

No


poly

%

lym

ph %

Eosi

n %

Mon

o %

Mon

o %

Safety Parameters MASTER CHART- PLACEBO CONTROL GROUP

ESR

mm

/1hr

Hb

gm %

TLC

cel

ls/c

umm

Baso

NSF

E

Baso

NSF

E

ESR

mm

/1hr

Hb

gm %

TLC

cel

ls/c

umm

poly

%

lym

ph %

Eosi

n %

Bloo

d ur

ea m

g/dl

Bloo

d ur

ea m

g/dl

S. C

reat

inin

e m

g/dl

SGO

T IU

/L

SGPT

IU/L


S. C

reat

inin

e m

g/dl

SGO

T IU

/L

SGPT

IU/L

1 6320 10.2 6100 70 19 10 1 0 13 2 9.8 4900 58 35 5 2 0 16 0 25 0.8 23 27 30 0.9 13 192 7144 16.8 13100 67 28 3 2 0 35 2 14.1 7600 52 41 5 2 0 9 0 30 1.2 28 38 27 1.2 32 483 7582 10.9 7500 52 45 2 1 0 4 2 10 7800 49 42 5 4 0 4 0 18 0.7 29 19 23 0.8 26 294 8497 14.2 6900 69 26 3 2 0 2 2 15.1 7200 63 33 2 2 0 2 0 24 0.9 27 25 22 0.9 25 175 9093 11.3 6700 55 36 5 4 0 54 2 12.5 8800 70 25 3 2 0 48 0 23 0.8 19 23 16 0.7 21 246 3176 14.7 7300 56 38 4 2 0 1 2 16.6 6700 51 44 3 2 0 12 0 39 1.1 35 41 23 0.6 30 357 8959 12.9 7500 36 58 5 0 1 2 2 13 6900 49 45 5 1 0 2 0 24 0.8 23 26 14 0.7 31 168 8746 14.8 9500 70 24 4 2 0 5 2 15.2 7700 48 46 4 2 0 4 0 31 0.8 37 53 21 0.8 25 449 10068 12.6 11100 67 28 3 2 0 25 2 12.4 10200 70 26 4 0 0 30 0 30 0.9 25 20 35 1.4 31 38

10 10312 14 6800 50 44 3 3 0 10 2 13.9 7000 52 42 4 2 0 9 0 34 1 31 39 31 0.9 35 2911 28067 13 10800 80 16 3 1 0 14 2 12.9 5600 60 34 5 1 0 23 0 29 0.9 24 20 18 0.8 19 2412 11139 15 10100 57 36 4 3 0 4 0 15.3 8900 56 37 4 3 0 5 0 35 0.9 37 44 22 0.9 36 4513 11251 12.6 9500 68 25 5 2 0 19 0 12.9 7400 57 35 5 3 0 22 0 29 0.7 16 13 15 0.7 16 1814 11287 16 9400 59 33 5 3 0 1 2 15 9300 61 33 5 1 0 1 0 32 0.9 24 19 26 0.9 20 2115 11932 16.8 10200 69 25 5 1 0 2 2 16.4 9500 60 33 6 1 0 2 0 22 0.6 42 78 15 0.7 33 6516 111193 15.4 6500 64 29 4 3 0 1 2 15.5 7000 69 25 3 3 0 1 1 18 1 19 18 19 0.7 27 3217 114902 16.5 8300 55 30 4 1 0 6 2 15.3 7200 49 46 3 2 0 4 0 15 0.6 37 39 20 1.1 25 4318 11049 12 8500 51 44 3 2 0 34 2 11.7 10800 51 43 3 3 0 39 0 24 0.8 22 27 25 0.9 18 1619 115473 12.9 9600 51 41 4 4 0 33 2 12.7 11000 54 38 4 4 0 16 0 20 0.7 18 20 28 1 19 1820 115621 14.9 7600 63 30 5 2 0 7 2 14.5 5400 51 40 5 4 0 7 0 24 1 14 20 19 1 30 5021 115762 15.6 8500 66 30 3 1 0 6 2 14.7 6800 60 32 4 4 0 10 0 14 0.8 21 20 19 0.8 22 2322 115249 16.3 6600 56 39 2 3 0 3 0 16.6 6500 53 39 6 2 0 2 0 17 0.9 13 19 21 0.8 11 2123 116645 16.5 8200 54 39 5 2 0 13 2 16.2 7100 46 49 4 1 0 8 0 19 0.8 26 31 17 1.2 18 2524 115165 17.8 8000 45 50 3 2 0 2 2 16.3 8100 45 50 4 1 0 4 0 24 0.9 29 41 17 0.9 23 3625 117313 15.4 10200 54 28 4 4 0 17 2 15.4 10200 54 28 4 4 0 17 0 22 0.9 35 71 22 0.9 35 7126 117893 15 7000 52 40 5 3 0 3 2 15.2 5200 51 44 3 2 0 3 0 17 0.8 41 77 20 1 52 5627 118616 13 9600 63 30 5 2 0 5 2 15 8700 58 37 3 2 0 8 0 25 0.8 33 50 24 0.7 34 5028 111502 11.5 8600 60 34 3 3 0 8 2 11.9 8300 47 46 4 3 0 14 0 17 0.8 17 15 23 0.6 23 2429 122410 12.5 8700 50 41 5 4 0 18 0 10.6 4650 58 38 3 1 0 47 0 25 0.9 18 17 15 0.7 19 1430 123793 14.5 9000 78 13 6 2 1 9 2 12.3 7800 67 24 6 2 1 14 0 25 1 39 26 26 1 25 33

Safety Parameters MASTER CHART - TEST GROUP

CR

No

S.N

o

Before Treatment

TLC

cel

ls/cu

mm

Mon

o %

poly

%

lym

ph %

After Treatment

Mon

o %

Objective Parameters

Eosin

%


poly

%ly

mph

%Eo

sin %

NSF

E

NSF

E

Hb

gm %

TLC

cel

ls/cu

mm

Baso

Baso

ESR

mm

/1hr

ESR

mm

/1hr

Hb

gm %

S. C

reat

inin

e m

g/dl

SGO

T IU

/L

SGPT

IU/L

Bloo

d ur

ea m

g/dl

S. C

reat

in m

g/dl

SGO

T IU

/L

SGPT

IU/L

Bloo

d ur

ea m

g/dl

Efficacy of a Unani formulation in Nazla Haar

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