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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However, giudelines still needs safe and effective options on a fast track. Instead, a robust assessment through systematic documentation and pharmacoepidemiological evidence[ 21 ] should suffice. The GCP is a set of guidelines to the industry which includes the design, conduct, audit, analysis, reporting, termination, and documentation of the clinical studies relating to human subjects. J Alt Compl Med.

The case of Ayurveda, however, is different as the treatment regimen is already in use. A proposed new discipline. The fourth criterion requires a historical control group.

Int J Ayurveda Res. Such approaches and protocols for TCM have already been developed and whole systems trials have been attempted. Such trials may also evaluate whole system interventions implemented under defined manuals and protocols, to specify individualized treatments based on specific patient characteristics.

Phase I trial sub: The Standard manufacturing practices and a well laid system of technical documentation of safety of products are two fundamental necessities of ISM sector was prominently missing for a long time. The fundamental tenet of GCP is that 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.

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Currently you have JavaScript disabled. The questions of Type 1 error and power in the traditional sense do not apply. Conducting clinical trials and generating evidence on the basis of these guidelines would help convincing the world about the potential scope of ASU remedies in scientific parlance and address the questions of lack of evidence and validation.

GCP – AYUSH Guidelines

The objective of this page log document is to encourage that clinical studies in ASU systems are undertaken in accordance with ethical and scientific standards and safety aspects and rights of participants are protected. Researchers have voiced this view in several countries over the last few years.

Enter the email address you signed up with and we’ll email you a reset link. Performing clinical trials and producing the proof on the basis of these guidelines would help believe the world about the prospective scale of ASU remedies in scientific jargon and tackle the questions of lack of facts and substantiation.

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.

Therefore, Indian scientists and regulators guideilnes design GCP guidelines after considering the epistemological differences between Ayurveda and Western biomedicine.

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AYUSH GCP GUIDELINES | CENTRALCOUNCILFORRESEARCHINSIDDHA PUBLICATIONS –

Eur J Clin Invest. This is difficult, as factual reporting could result in biased, under-powered or ethically unacceptable research.

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Inhibition of mutated, activated BRAF in metastatic melanoma. 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.

Informed Consent in Non-Therapeutic Study: Apr 19, 1: However, all paediatric participants should be informed to the fullest extent possible about guidelinees study in a language and in terms that they are able to understand.

Finally, the fifth criterion requires recent advances in guidelinee scientific appreciation of the theory of Ayurveda’s fundamental concepts. The audit should also compare data on the Source Documents with the interim or final report. Your email address will not be published.