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The Research Committee on Traditional Medicine of the NSF recently held a training workshop on the development of protocols for clinical trials of Ayurvedic drugs. The main objective was to create awareness on how to conduct clinical trials of Ayurvedic drugs on Vitiligo and Rheumatoid Arthritis and to encourage more scientific and reproducible research in Traditional Medicine.

Pro. Ranjan Ramasamy, Chairman, NSF stated that traditional medicine is one aspect of traditional knowledge and unfortunately traditional knowledge is commonly and incorrectly associated only with non-European countries. On the contrary, valuable drugs like Digoxin have been developed from traditional plant-based therapis in European countries. Further, he said that we should make an effort to develop our own traditional medicine more scientifically. He also said that it would be more appropriate to replace the term "western medicine" with "modern medicine" since the former had strong Eastern inputs, particularly from the Arab World.

Dr. Michael Eddleston, Specialist Registrar in Clinical Pharmacology/Toxicology and General Medicine at the Centre for Tropical Medicine, Oxford University and Department of Clinical Medicine, University of Colombo, giving a general overview on clinical trial methodology, discussed the different types of studies that can be performed such as Randomized controlled trial, Non Randomized controlled trial, Case control study, Cross sectional study etc. He emphasized that a researcher should try to make the inclusion of possible patients into the trial-make entry criteria as wide as possible. If only a small group of patients are studied, the results of the trial may not be valid for most other patients.

Dr. T. Varagunam, formerly of the WHO, spoke on the world situation in traditional medicine clinical trials and said that there is an increasing interest in all countries in the use of traditional medicine for the treatment and prevention of illnesses. In the developing countries, traditional medicine continues to be an important part of health care and is often the only form of health care available in many parts of Africa.

The most common conditions for which studies of Ayurvedic therapies have been published are, diabetes mellitus, hepatitis, infectious diseases, hypercholesterolemia and central nervous system disorders (dementia/depression). It was documented that the roots of the Thunder God Vine, a plant whose leaves and flowers are highly toxic, have been used medicinally in China for over 400 years. A root extract of this plant was shown to safely and effectively reduce pain and inflammation in a small group of people with treatment-resistant rheumatoid arthritis, according to a study, which was the first test funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, (NIAMS), in the USA.

Dr. Sarath Ranasinghe, Senior Lecturer of the Institute of Indigenous Medicine presented his views on the development of protocols for clinical trials of Ayurvedic drugs in Rheumatoid Arthritis. He said that for literary/descriptive purposes in Ayurveda, the name given for Rheumatoid Arthritis is Amavata. According to him, the Ayurvedic approach to research is different from that of modern medicine where research on clinical trial is the testing of a drug to see whether a particular drug is effective for a particular disease. In Ayurveda, there are three main ways to carry out research. These are research on disease, treatment and drugs. Selection of patients for a clinical trial is done on the history, symptomatology and clinical picture. Chronically ill patients with severely deformed joints are generally excluded.

Dr. Lalith Wijeratne, of the National Hospital of Sri Lanka gave the modern medical view point regarding the carrying out of research on clinical trials on Rheumatoid Arthritis. He said that western medical practitioners and Ayurvedic physicians should share their knowledge. He explained the basic principles of clinical trials on Rheumatoid Arthritis.

According to practitioners of western medicine, it is an autoimmune disease in which our immune system gets out of control and starts attacking our own structures. He said that though we have no clear data in Sri Lanka, 1%-2% of the total population in developed and developing countries suffer from Rheumatoid Arthritis. Generally, disability, pain and distress are the common symptoms of the disease. Dr. Wijeratne explained how the immune system acts during the acute phase through a combination of lymphocytes, antibodies and cytokines towards joint destruction.

Dr. H. A. S. Ariyawansa, Senior Lecturer from the Institute of Indigenous Medicine spoke on the development of protocols for clinical trials of Ayurvedic Drugs on Vitiligo (Switra). He said the objectives of the protocol should be (i) to study and interpret aetiopathological and clinical profile from an Ayurvedic view point; (ii) to study and evaluate the efficacy of an Ayurvedic drug (single/compound, external/internal) on Vitiligo; (iii) to study the trial drug from an Ayurvedic pharmacological perspective and to understand the possible mode of action of the trial drug; (iv) to study side effects of the trial drug.

A well-known dermatologist, Dr. Ganga Sirimanna from the NHSL gave an overview on Vitiligo which is a common skin disease and said that the worldwide incidence of the disease is 1% of the population. She pointed out that since Vitiligo is visible most of the time, it has a social impact too. Vitiligo is caused by the acquired loss of melanocytes resulting in depigmentation of the skin. Dr. Sirimanna said pathogenesis of Vitiligo may be due to several mechanisms such as, (i) autoimmunity or the development of antibodies and cellular responses against self antigens of melanocytes, (ii) nervous mechanisms.

Clinical features of Vitiligo start as a small patch and enlarge to cover a large area, and according to Dr. Sirimanna if the hairs are black there is more potential for recovery because this shows that there are intact melanocytes in the follicular epithelium. There are certain diseases producing similar symptoms, such as Systematic Lupus Erythromatosis and Chemical Leucoderma which should not be mistaken for Vitiligo. Vitiligo can affect people at any age but is mostly seen among the 20-38-year age group. Vitiligo is a gradually progressing disease, but sometimes rapid progress and has been noted and spontaneous depigmentation documented.

Finalized protocols prepared by Dr. Sarath Ranasinghe and Dr. H. A. S. Ariyawansa on Rheumatoid Arthritis and Vitiligo including allopathic view points are available at the NSF for those who are interested.

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