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LBM 5

CLINICAL TRIAL AND SCIENTIFICATION OF TRADITIONAL HERBAL MEDICINE

STEP 1

Scientification : measure the herb or simplicia before made into jamu, ex: use 5 leafSTEP 2

1. How is the proces of scintification traditional herbal medicine?

2. What is the different in clinical trial between convensional medicine and traditional

herbal medicine?

3. How is te regulation of scientification traditional herbal medicine?

4. What is the rules of clinical trial

5. What is the purpose of scientification traditional herbal medicine?

STEP 3

1. How is the proces of scintification traditional herbal medicine?

2. What is the different in clinical trial between convensional medicine and traditional

herbal medicine( fitofarmaca)?

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3. How is te regulation of scientification traditional herbal medicine?

Dalam rangka menyediakan bukti ilmiah terkait mutu, keamanan, dan manfaat obat tradisional (jamu),

maka Pemerintah Indonesia, dalam hal ini Kementerian Kesehatan RI, telah mengeluarkan Peraturan

Menteri Kesehatan No. 03/MENKES/PER/2010 tentang Saintifikasi Jamu. Saintifikasi Jamu adalah

pembuktian ilmiah jamu melalui penelitian berbasis pelayanan kesehatan.2 Salah satu tujuannya adalah

memberikan landasan ilmiah (evidenced based) penggunaan jamu secara empirik melalui penelitian

berbasis pelayanan yang dilakukan di sarana pelayanan kesehatan, dalam hal ini klinik pelayanan

jamu/dokter praktik jamu. Untuk menjalankan Saintifikasi Jamu sesuai dengan Peraturan MenteriKesehatan No. 03/MENKES/PER/2010, maka telah ditetapkan Keputusan Menteri Kesehatan No.1334

Tahun 2010 tentang Komisi Nasional Saintifikasi Jamu, yang salah satu tugasnya adalah menyusun

pedoman metodologi penelitian jamu.

4. What is the rules : method, subject ,of clinical trial

There are 4 phase

1. The trial give to the healthy volunteer (how many)

2. EarlyThe trial give to the specifict voluteer with limited patient

without comparison

Last The trial give to the specifict voluteer with limited patient with

comparison.3. Involve large of patient

4. Post marketing surveillance

Method

We have to use the gold standartRCT and double blind

And for subject there is no sicnificant different between fitofarmaca and convensional

medicine. And subject based on the disease.

5. What is the purpose of scientification traditional herbal medicine? To increase served safety jamu with effication based on research

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To make a conection between doctor ,dentist and other health provider as scientist

to increase preventif ,promotif, kuratif ,rehabilitatif .

6. The obstacle of clinical trial ?

Standaritation

Blinding method Inform consent

7. What is the diffrent between clinical trial of fitofarmaca and scientification of traditional

herbal medicine

The compisition of fitofarmaca can be mixed into less than 5 simplicia but

traditional herbal medicine doesnt have limitation of simplicia

Fitofarmaca used the complete clinical trial

Traditional medicine doesnt need the complete clinical trial.

Scientification of traditional

herbal medicine

Based on empiric data

Need measure about

herb/simplicia

Knowing active

component

Traditional Herbal

Medicine

phitofarmaticals

Need clinical trial ( subject,

method,phase

1. Phase 1 : just healthy

surveilance

2. Phase 2 : early

patient withoutcomparison

Endpatient with

comparison

3. Phase 3 : indication

4. Phase 4 :

postproductionn

Regulation of traditional

herbal medicine Kepmenkes No

1109/ 2007

(tradcam)

Kepmenkes003/

Menkes/Per/201

0 ( purpose of

scientification)

Kepmenkes

121/SK/2/2008

(standart ofmedical herbal

provider