Clinical Trial for Herbal Medicine

 

Indonesia is rich with natural resources potentials including herbal medicine. As a tropical country, Indonesia is the second largest country to produce herbal medicine after Brazil. It has been a long time that our ancestors make use of herbal medicines to maintain their health and cure diseases. One of the form is called jamu.

What is a clinical test?

A clinical trial is a research that is addressed to man as a subject. Generally, this is done to a patient. The clinical trial or also called an experimental research is classified into four phases. i.e. phase I, phase II, phase III, and phase IV. The four phases of clinical trial can be seen in the following table.

Tabel 1. Clinical Trial Phases and Their Characteristics (Bennet & Brown, 2008)

Types of Clinical Trial	Purpose	Methods & Design
Zero Phase	Preliminary study on man about chemical compound and new agent.	Quasi or historical experiment (pre-post design).
Phase I	Clinical Pharmacology. Safe dosage, tolerability and pharmacokinetic profile, medical pharmacodynamics and food effect.	20-80, healthy volunteer subject or patient suitable therapeutic class, historical or quasi trial clinic (pre-post study).
Phase II	Therapeutic effect exploration. Effective dosage and safe dosage range, safety especially to predict AE and pharmacokinetic profile, additional pathophysiology mechanism data, before release of medicine. Pact of new therapy	30-300, little number of patient subject; open label clinical trial.
Phase III	Confirmation of therapeutic effect. Eviction, pharmaco-economy, and safety trial on enough sample and representative before medicine gets legal permit for distribution.	250-1000, suitable patient subject with inclusion criteria with big number; RCT parallel or cross over.
Phase IV/post marketing surveillance	Therapeutic effect evaluation. ADR, safety  level, and other effect/indication monitoring after medicine distribution	2000-10.000, subject: sick patient; analytical observation or case series.

Herbal medicine-clinical trial is a herbal medicine examination on man. Generally a clinical trial is done after desired prepared medicine undergoes pre-clinical trial, which is applied on animals. Yet, herbal medicine-clinical trial can undergo two approaches i.e. the trial as jamu and non-jamu. For herbal medicine as jamu, the clinical trial can be done without pre-clinical trial. But, for herbal medicine non-jamu to come to clinical trial, it follows the normal procedure i.e. from pre-clinical trial up to clinical trial phase 4.

Clinical trial is done to guarantee the medicine’s advantages as well as safety. Not all herbal medicines are free from side effects so that clinical trial is needed to avoid the danger for public. Nevertheless, clinical trial requires human resources and much fund.

University of Ahmad Dahlan (UAD) through its Pharmacy Faculty made use of government grant to carry out clinical trial for herbal medicine composed of rosela, tonglat ali, and black jinten.