Role of Clinical Trials in Herbal Product Development: A Review

Ayurveda, Unani and Siddha are the medical systems primarily practiced in India that has been known for nearly 5000 years.It includes diet and herbal remedies, while emphasizing the body, mind and spirit in disease prevention and treatment.The herbal industry has grown rapidly due to increasing demand for natural remedies and traditional medicines.Herbal medicine is the mainstay of about 75 -80% of the world population, mainly in the developing countries for primary health care.India's domestic herbal industry is represented by thousands of licensed herbal units, thousands of cottage level unregulated herbal units and millions of folk healers and house hold level users of thousands of herbal raw drugs on one hand and a complex trade web on other, which channels the herbal raw drugs from various supply sources to the end users.WHO has issued Guidelines for the Assessment of Herbal Medicines.These guidelines defined the basic criteria for the evaluation of quality, safety and efficacy of herbal medicines with the goal of assisting national regulatory authorities, scientific organizations and manufacturers in assessing documentation, submissions and dossiers in respect of such products.Clinical trials are essential in developing treatments for rare diseases.Rare diseases affect a small percentage of the population, making it difficult to conduct large-scale studies on new treatments.However, there are several challenges for the herbal industries that inhibits the growth of ayurvedic products.