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 leaf

STEP 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)?

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 Menteri
Kesehatan 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. Early The 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 standart RCT 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

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.
Traditional Herbal
Medicine

phitofarmaticals

Scientification of traditional
herbal medicine

Based on empiric data

Need measure about
herb/simplicia
Knowing active
component

Regulation of traditional
herbal medicine
Kepmenkes No
1109/ 2007
(tradcam)
Kepmenkes003/
Menkes/Per/201
0 ( purpose of
scientification)
Kepmenkes
121/SK/2/2008
(standart of
medical herbal
provider

Need clinical trial ( subject,

method,phase
1. Phase 1 : just healthy
surveilance
2. Phase 2 : early
patient without
comparison
End patient with
comparison
3. Phase 3 : indication
4. Phase 4 :
postproductionn