AYUSH GCP GUIDELINES PDF

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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Ramesh Shankar, Mumbai Thursday, April 18, However, all paediatric participants should be informed to the fullest extent possible about the study in a language and in terms that they are able to understand. A proposed new discipline.

Ayurveda GCP Guidelines: Need for freedom from RCT ascendancy in favor of whole system approach

National Center for Biotechnology InformationU. Therefore, Indian scientists and regulators should design GCP guidelines after considering the epistemological differences between Ayurveda and Western biomedicine. 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.

Understanding the underlying Ayurvedic biology, physiology, pathology, pathways, and mechanisms through which treatments exercise their benefits is far more important. In the case of Ayurveda, its dosha prakriti theory of disease susceptibility and dosha vikriti approach to etiology are increasingly well understood. Moreover, instead of using single chemical entities, Ayurveda uses herbal medicines, and more complex, yet systematically determined regimes of diet ahara and lifestyle viharabased on increasingly well-understood Ayurvedic physiological principles such as Prakriti.

Click here to sign up. Such Indianized, innovative guidelines on GCP for ASU would not only give due respect, leadership, and a major boost to this sector, but also offer freedom from the over-dominance of RCTs. Boon for the safety and efficacy of ayuvedic formulations.

Miller FG, Joffe S.

Recommending equivalence trial design and proposing safety index. J Alt Compl Med. Apr 20, 1: The fourth criterion requires a historical control group. The case of Ayurveda, however, is different as the treatment regimen is already in use. Immense opportunities thus lie ahead for the stakeholders to adopt the guidelines as a tool for promoting scientific and quality clinical research for credible outcomes.

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Help Center Find new research papers in: Log In Sign Up. It is reasonable to judge the success of Ayurvedic treatments in terms of Ayurvedic endpoints and not be limited to endpoints selected by the western biomedicine approach. In case of Ayurveda for instance, patients are already using its treatments and therefore effectiveness giidelines can guide the necessity of studying the efficacy of specific components.

The label should necessarily contain the following information: The objective of this page log document is to ayuxh that ayuh studies in ASU systems are undertaken in accordance with ethical and scientific standards and safety aspects and rights of participants are protected.

Therefore, rather gvp performing RCTs of Ayurveda treatments, future research efforts should focus on robust documentation and understanding their mechanisms and their importance as an affordable and safe healthcare system.

Conceptual framework for new models of integrative medicine. Skip to main content. As such observational studies, meta-analyses, case studies and case series, and an effective pharmacovigilance program are much more in keeping with the needs of the situation, it is important to note that even though observational studies or case studies or case series could be biased, as a body of knowledge they are scientifically unbiased.

The questions of Type 1 error and power in the traditional sense do guuidelines apply. Adhering to methodical documentation of trials will help bringing credibility to the efforts of persons and institutions xyush in the process, which otherwise was lacking for want of any ASU-specific guiding document.

The black box approach, pragmatic trials, and the whole system guidelnies of Ayurveda needs to be maintained rather than accepting ayusn methods of treating any symptom or disease condition in isolation. The guidelines fulfill a long felt need to guide the direction of clinical trials on ASU remedies and therapies. 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.

They appear to be largely based on the standard GCP guidelines previously proposed by the Central Drugs Standard Control Organization[ 3 ] and need more attention to the special needs of the ASU sector. Studies in Phase III may also further explore the dose-response relationships relationships among dose, and clinical responseuse of the drug in wider populations in guidleines stages of disease, or the safety and efficacy of the drug in combination with other drug s.

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Instead, a robust assessment through systematic documentation and pharmacoepidemiological evidence[ 21 ] should suffice. Patwardhan B, Bodeker G.

Informed Consent in Non-Therapeutic Study: Traditional Medicine to Modern Pharmacogenomics: Traditional medicine and genomics. Special thanks to Ashwini Mathur of Novartis Ayhsh and Roy Chengappa from the University of Pittsburgh for their critical comments and suggestions. Mature minors and adolescents should personally sign and date separately designed written assent form.

Good Clinical Practice (GCP) guidelines to provide new direction for ASU trials | JLI Blog

Eur J Clin Invest. A CRF may be in printed or electronic format. 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. Studies in this Phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteers subjects or certain types of patients.

This strong empirical evidence may be considered in Ayurveda’s favor. In fact, we need to evolve appropriate guidelines based on the basic principles of Ayurveda where due weightage is given to empirical evidence.

They suggest five conditions, for which when satisfied, an RCT should not be deemed necessary. Health Care and Risk Management: The intention of this page manuscript is to persuade that clinical studies in ASU systems are conducted in agreement with ethical and scientific standards and safety issues and rights of study subjects are protected at all stages of trial conduct. In case of many chronic diseases, life expectancy and quality of life are reduced with a risk of iatrogenic disease.

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.

Good Clinical Practice Guidelines for clinical trials of ASU Medicine

Unconventional wisdom in medicine. However, the proposed guidelines seem to have been drawn up on the basis of Western biomedical approaches, including randomized controlled trials, as necessary evidence. A Decadal Vision Document –