Problems associated with clinical trials of Ayurvedic medicines / Problemas associados com ensaios clínicos de medicamentos Ayurvédicos

ABSTRACT

Herbal drugs have been used since ancient times as medicines for the treatment of various diseases. Especially in countries like India many of herbal drugs and formulations are used in different practices of treatment like Ayurveda, Siddha and Unani. It is estimated that about 25 percent of all modern medicines are directly or indirectly derived from plants sources. The contribution of developing countries in global herbal business is very poor due to lack of quality control and standardization measures. There is lack of common standards and appropriate methods for evaluating Traditional Medicine to ensure the safety, efficacy and quality control. This indicates the importance and necessity to develop a standard operational procedure for the standardization of herbal drugs and formulations. Benchmarking the evaluation protocols including both quality control and quality assurance of herbal drugs would play a major role in providing highly reliable and effective herbals drugs and to attract international trade, thus generating revenue. The article highlights various problems being faced by developing countries and suggests a unique approach for the preparation of SOP/guidelines for the standardization of all herbal based formulations, also there is a need for systematic clinical trials of traditional plant based medicines to enhance global acceptance