Uji Klinik Fase II Ramuan Jamu sebagai Pelindung Fungsi Hati

zuraida - zulkarnain, Fajar - Novianto, Saryanto - Saryanto

Abstract


Abstract
The human liver is susceptible to interference due to its complex function. The development of
hepatoprotective from jamu formula is still needed as to produce more effective, cheaper and
safer hepatoprotective. The result of previous study showed that the hepatoprotective from jamu
formula was safe and efficacious. This phase 2 trial was conducted to evaluate the efficacy and
safety of hepatoprotective from jamu formula which consists of Curcuma longa rhizomes, Curcuma
xanthorrhiza rhizomes, and Taraxacum officinale leaves. The design was open label randomized
clinical trial with silimarin as a comparison for 42 days intervention. Two hundreds of human
subjects participated in this study. The trial held in 2015 and involved 50 physician members of
Saintifikasi Jamu Network at several regencies in Indonesia. The parameters for assessing efficacy
were SGPT, SGOT and as for safety were routine blood, urea, and creatinine. Clinical symptoms and
possible side effects were also observed. The results showed that the jamu formula can reduce the
average value of SGPT and SGOT equal to silimarin. Jamu formula can relieve clinical symptoms
arising from liver function disruption, and it is safe, it does not alter kidney function, hemoglobin,
leukocyte count and platelet count in its use for 42 days.
Keywords: hepatoprotective, Saintifikasi Jamu, Curcuma longa, Curcuma

 

Abstrak
Hati mudah mengalami gangguan disebabkan fungsinya yang kompleks. Saat ini masih diperlukan
pengembangan ramuan jamu untuk melindungi dan memperbaiki sel-sel hati (hepatoprotektor) yang
lebih efektif, murah dan aman. Hasil penelitian observasi klinik terdahulu menunjukkan bahwa
formula jamu untuk hepatoprotektor aman dan berkhasiat sehingga dilanjutkan dengan uji klinik fase
2. Tujuan uji ini untuk menilai khasiat dan keamanan ramuan jamu sebagai hepatoprotektor dengan
komposisi rimpang temulawak, rimpang kunyit, dan daun jombang. Rancangan uji adalah open label
randomised clinical trial dengan pembanding silymarin dan lama perlakuan 42 hari. Jumlah sampel
200 subjek manusia. Uji ini melibatkan 50 dokter jejaring saintifikasi jamu di beberapa wilayah di
Indonesia pada tahun 2015. Parameter untuk menilai khasiat adalah SGPT, SGOT dan untuk menilai
keamanan adalah darah rutin, ureum, kreatinin. Gejala klinis dan kemungkinan efek samping juga
diamati. Hasil uji menunjukkan bahwa ramuan jamu uji mampu menurunkan rerata nilai SGPT dan
SGOT sebanding dengan silymarin. Ramuan jamu uji dapat meredakan gejala klinik yang timbul
akibat gangguan fungsi hati, aman, tidak mengubah fungsi ginjal, hemoglobin, angka leukosit
maupun angka trombosit pada penggunaan selama 42 hari
Kata kunci : hepatoprotektor, Saintifikasi Jamu, kunyit, temulawak, jombang


Keywords


hepatoprotektor, Saintifikasi Jamu, curcuma, temulawak

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Buletin Penelitian Kesehatan (Bulletin of Health Research, p-ISSN: 0125-9695. e-ISSN: 2338-3453) is published by Badan Penelitian dan Pengembangan Kesehatan, Ministry of Health of Republic of Indonesia
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