The Department of Ayush has initiated a multicentric clinical trial project through the Central Council for Research in Ayurveda and Siddha (CCRAS), on 29 classic formulations in 18 disease areas like diabetes mellitus, hypertension and obesity to back them with clinical efficacy and safety data.

The clinical trials will be conducted on classical formulations from ancient books which is considered as the time tested therapeutics and the real strength of Ayurveda and not the patent or proprietary medicines. The council has identified and selected 54 MD or Ph.D (Ayurveda) students in eight Post-graduate Ayurveda Colleges across the country and is sensitising them for the project through workshops, according to high level sources from CCRAS.

The objective is to create clinical data to back the classic formulations, which are mentioned in the Ayurvedic Pharmacopoeia of India (API) as an activity under the Ayurvedic Pharmacopoeia Committee (APC). The project is envisaged to prove scientifically the safety and efficacy of the ancient ayurvedic preparations as internationally acceptable, said the source. The study is expected to give result in the next three years' time, he added.

The council would act as the nodal organization to co-ordinate and monitor the trials by providing necessary infrastructure to the participating colleges, technical inputs including the clinical trial protocols, trial drugs and training to the researchers involved in the project.

The formulations selected as trial drugs would be sourced from the Kottakkal Arya Vaidya Sala (KAVS), Kerala, Dabur India, Uttar Pradesh and the Indian Medicines Pharmaceutical Corporation Ltd, Mohan, Uttarakhand.

The council is also providing one semi-automatic biochemistry analyzer to each of the clinical trial sites to facilitate the laboratory investigations during clinical trials and to maintain uniformity of the test results. Besides, Rs.25,000 would be paid to each scholar to meet the cost of reagents and kits for conducting the laboratory investigations in addition to a grant of Rs.5,000 per student towards contingency. The council is also facilitating each scholar with equipments for daily reporting as per the e-format of the case record forms.

The efficacy and safety of Bilvadi Lehya for treating Irritable Bowel Syndrome, Ashokarishta, Ashwagandha Churna and Praval Pishthi for Menopausal Syndrome, Laksha Guggulu and Mukta Shukti Pishti for Osteoporosis, Punarnavadi Mandura and Dadimadi Ghrita(B) for Iron Deficiency Anemia, Ashvagandhadi Lehya for Rasayana, Kanchanara Guggulu and Varun Kwath Churna for benign prostatic hyperplasia (BPH), Vyaghri Haritaki Avaleha for Bronchial Asthma and Bronchitis and Ashwagandhadyarishta, Jatamamsi Arka and Sarpagandha churna for Hypertension are to be studied through the project.

Other classic drugs and the disease areas selected for the study includes Palash Kshara and Pashanbheda Kwatha Churna for Urolithiasis, Vyoshadi Guggulu and Haritaki churna for Dyslipidemia, Vyoshadi Guggulu and Haritaki churna for Obesity, Brahmi Ghrita and Jyotishmati Taila for Cognitive deficit, Punarnava Guggulu, Dashmoola Ghrita and Kottamchukadi Taila for Osteoarthritis, Brihata Saindhavadi Tailam and Simhanaada Guggulu for Rheumatoid Arthritis, Maha Triphaladya Ghrita for Dry Eye Syndrome and Simple Allergic Conjunctivitis and Saptavimshatika Guggulu and Haridra Churna for Diabetes Mellitus.