CLINICAL TRIALS OF TRADITIONAL HERBAL MEDICINES IN INDIA: CURRENT STATUS AND CHALLENGESAbstract
Traditional herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products that contain active ingredients parts of plants, or other plant materials, or combinations. Clinical trials of traditional herbal medicines are carried out with herbal preparations only after standardization and identification of markers to ensure that the substances being evaluated are always the same. It is very important to assess the direct and indirect risks associated with traditional herbal medicines. This can only be established once the safety and efficacy of herbal medicines are being proven during clinical trials. There are various concerns over the clinical trial designs in India. It has been observed that during clinical trials various problems are being observed such as Batch to batch variation, use of placebo instead of innovative product, inadequate quality control system, the inadequate requirement for the assessment of safety and efficacy for different types of herbal medicines and difficulty in quantification due to complex nature of extract. This review focuses on the current status of clinical trials of traditional herbal medicines in India, and an attempt has also been made to review the problems encountered during conduction of clinical trials and suggestions and recommendations are also provided to ensure that the clinical trials can be conducted with safety and efficacy.
H. P. Singh *, S. Sharma, S. B. Chauhan and I. Kaur
AIMIL Pharmaceuticals (I) Limited, Naraina, New Delhi, India.
17 March 2014
13 June 2014
29 June 2014
01 July 2014