The Central Council for Research in Ayurveda and Siddha (CCRAS), a research body under the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), is initiating clinical trials on two of its new drugs to support cancer patients and mental retardation in children.
The clinical trial on Ayush QOL 2-c, a plant-based herbal formulation standardised as per the prevalent norms and extensively screened for many biological activities in view of its Rasayana effects, will be commenced in four centres in various parts of the country soon, informed Dr G S Lavekar, director, CCRAS. The formulation is expected to improve the quality of life in patients receiving chemo, radio or chemo radio therapy for various types of cancer.
"The protocol for the clinical trial has been prepared and we are also on the process of filing patent for the product. The drug is developed by CCRAS on system biology basis and we are planning for technology transfer once the clinical trial is completed successfully in the next two years. Even at this stage of development, we are ready to involve an industry partner who can take over the technology later," said Dr Lavekar.
The study will be conducted in four centres, the Cancer Research Centre under the All India Institute of Medical Science (AIIMS), St John Medical College Hospital, Bangalore, Mahavir Cancer Research Institute and Hospital, Jaipur and the Mumbai Cancer Institute.
Ayush Manas, the formulation developed by CCRAS for mental retardation in children, based on system biology and standardised on par with prevalent parameters is also ready for clinical trials. The protocol for the drug is ready and the human studies will be initiated in Dr Ram Manohar Lohia Hospital, New Delhi and National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore soon.
Ayush-Os, a formulation for osteoporosis and fracture, Ayush SL for filariasis, which is developed joinitly with the ICMR Vector Control Research Centre, Puducherry, and Ayush-M for Migraine are the other projects which are under development in the council, said Dr Lavekar.
Fruther, four other formulations developed by the CCRAS, Ayush Rasayan-(A) and Ayush Rasayan-(B), the rasayana preparations for elderly persons, Ayush-RP for sickle cell anaemia and Ayush-LIV for Hepatitis A and C, has already completed standardization, acute toxicity, chronic toxicity and biological activity studies, according to the official reports.