AYUSH – GCP Dr Sathiya Rajeswaran Research Officer SCRI,CCRS,Chennai All roads meet a common goal Roads are different goal is same • ICMR • WHO. ‘Good Clinical Practice Guidelines’ published by AYUSH Ministry for clinical trials of Ayurveda, Siddha & Unani drugs. There are four Research. The department of Ayush has issued good clinical practice (GCP) guidelines for clinical trials in Ayurveda, Siddha and Unani (ASU) medicines.
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National Center for Biotechnology InformationU. Help Center Find new research papers in: Guiedlines Case Record Form should be in such a form and format that allows accurate input, presentation, verification, audit and inspection of the recorded data.
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. For not only have medical researchers questioned the process but some leading ayysh have directly written to the Drug Controller of India to ban its use. This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.
The second criterion requires evidence for large effect sizes from earlier studies. The audit should also compare data on the Source Documents with the interim or final report. Efficacy and safety of Ayurvedic medicines: Eur J Clin Invest. Traditional medicine and genomics. J Asso Physicians India.
Good Clinical Practice Guidelines for clinical trials of ASU Medicine
Miller and Joffe’s criteria may be generalized to Ayurvedic treatments. Bioethics emphasizes that patients come first and proper efforts are made to ensure respect, justice, and beneficence. The conceptual framework for new models of integrative medicine[ 16 ] and Indian guidelines for GCP must stem from the principles guidelunes practices of Ayurveda.
Plethora of opportunities thus lies in front of the stakeholders to embrace the guidelines as a tool for encouraging scientific and reliable clinical research for plausible outcomes.
Ayurveda GCP Guidelines: Need for freedom from RCT ascendancy in favor of whole system approach
This is how many drugs have found place in modern medicine, the best example being aspirin, where its anti-inflammatory and analgesic properties were recognized long before its mechanism of influencing prostaglandin synthesis was understood.
The fundamental tenet of GCP is guiddelines in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject.
EGLN1 involvement in high-altitude adaptation revealed through genetic analysis of extreme constitution types defined in Ayurveda. Miller FG, Joffe S. J Alt Compl Med. N Engl J Med.
Also, Ayurveda advocates the personalized approach in treatment of patients. If we attempt to do so, the global scientific community should also benefit, where the relevance of RCTs in the light of integrative medicine has already been greatly debated for better alternatives.
A catalogue of reporting guidelines for health research. Adhering to methodical documentation of trials will help bringing credibility to the efforts of persons and institutions involved in the process, which otherwise was lacking for want of any ASU-specific guiding document. In the conventional RCT model, efficacy is often determined before assessing effectiveness, which is now considered unethical.
J Ayurveda Integrat Med. Scientific unbiasedness is different from unbiasedness that is used generally.
The guidelines are addressed to investigators and all those, who are interested, concerned, involved and affected with the conduct guideliens clinical trials on ASU drugs.
These studies should be intended to provide an adequate basis for marketing approval for ASU Drugs. Measures to be implemented to ensure the safe handling and storage of theASU Medicine. To summarize, when the world is waking up and seriously debating the need for newer models for clinical research, Indian guidelines for ASU should not get overwhelmed by the RCT approach of biomedicine.
AYUSH GCP GUIDELINES | CENTRALCOUNCILFORRESEARCHINSIDDHA PUBLICATIONS –
Finally, the fifth criterion requires recent advances in the scientific appreciation of the theory of Ayurveda’s fundamental concepts. This is difficult, as factual reporting could result in biased, under-powered or ethically unacceptable research.
Such trials may also evaluate whole system interventions implemented under defined manuals and protocols, to specify individualized treatments based on specific patient characteristics.
Apr 22, 6: Studies in this Phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteers subjects or certain types of patients.