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Clinical Research in Ayurveda
The term Ayurveda" combines the Sanskrit words ayur (life) and veda (science or knowledge). Thus it is"the science of life."Ayurvedic medicine the aim of which is to integrate and balance the body, mind, and spirit, believed to helpful in prevention of illness and promotion of wellness, is one of the world's oldest medical systems, originated and evolved over thousands of years in India.
Ayurvedic treatments rely on herbs and other plants, including oils and common spices. About, 600 herbal formulas and 250 single plant drugs are included in the "pharmacy" of Ayurvedic treatments, currently, described in texts issued by national medical agencies in India. Sometimes, herbs or herbal extracts are mixed with metals or other naturally occurring substances to make specific formulas according to Ayurvedic texts.
Though, in the United States, Ayurvedic medications are regulated as dietary supplements and are not required to meet the safety and efficacy standards prescribed for conventional medicines, a study published in 2004 found that of 70 Ayurvedic remedies purchased over-the-counter (all manufactured in South Asia), 14 contained lead, mercury, and/or arsenic at levels that could be harmful and another study conducted in 2004 by the Centers for Disease Control and Prevention, reported that 12 cases of lead poisoning were linked to the use of Ayurvedic medications over a period of 3-years.
Most clinical trials of Ayurvedic approaches have been uncoordinated efforts and have been conducted in isolation; most had problems with research designs, lacked appropriate control groups, or had other issues that affected how meaningful the results were. Therefore, scientific evidence for the effectiveness of Ayurvedic practices varies, and more rigorous research is needed to determine which practices are safe and effective.
Ayurveda research has been priority of Indian Government. It is indeed laudable that Government of India has created a department of AYUSH and has played a big role in developing scientific proof for drugs of Indian System of Medicine and popularizing Ayurvedic education in India.
National Knowledge Commission has said that if the Indian System of Medicine is to get proper recognition and credit and a glorified status in minds of common man, we need to work towards evidence based Indian System of Medicine.
The department of Ayush in 2013 has issued good clinical practice (GCP) guidelines for clinical trials in Ayurveda, Siddha and Unani (ASU) medicines which will facilitate the researchers and institutions in adopting a standard practices during conduct of ASU clinical trials according to a set of guidelines which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects.
It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine under investigation are properly documented. The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of data generated during clinical trial of ASU medicine.
Though voulantary, researchers, sponsors and drug manufacturers, have to be well versed with the standard scientific procedures that are required to be followed while conducting clinical trials with ASU interventions to achieve objective and reproducible results.
Considering the importance of scientific and ethical Ayurveda Clinical research, Maharashtra University of Health Sciences (MUHS), Nashik has established its very own department of AYUSH at its head quarters and Ayurveda Clinical Trial Units(ACTUs) in its regional centres, namely at Pune, Mumbai, Aurangabad and Nagpur. All MUHS affiliated Ayurveda Colleges hospitals in the state will be involved in this network as trial sites and Ayurveda faculty working in such institutes as researchers for submission of study protocol under different schemes(EMR,PHI etc) of department of AYUSH, New Delhi through MUHS regional ACTUs and MUHS, department of AYUSH, Nashik.
Each study protocol submitted at regional ACTU will be scrutinized by Scientific Advisory Committee (SAC), Community advisory committee and Ethics Committee. The approved protocol would then be forwarded to department of AYUSH, New Delhi through MUHS headquarters at Nashik. The study, after approval from department of AYUSH will be conducted at trial sites decided by MUHS, department of AYUSH. The regional ACTU, where the protocol was submitted initially would act as trial monitoring, coordinating and data processing centre for the data gathered at each site included in the study. It is to be noted that ACTU, Pune has already submitted seven projects to AYUSH Department, New Delhi under EMR scheme and two projects under PHI scheme are at the stage of submission.
This setup would lead to better coordination about clinical research conducted in the state and avoid duplicate/similar protocols according to needs of local community, avoid directionless/unidirectional research and save researchers valuable time and intellectual effort.
ACTU Pune has already submitted seven projects to AYUSH Department New Delhi under EMR scheme and two projects under PHI scheme are at the stage of submission.