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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Ayurveda GCP Guidelines: Need for freedom from RCT ascendancy in favor of whole system approach
We should learn and quickly adopt appropriate reporting standards on lines similar to Consolidated Standards for Reporting Trials CONSORT [ 22 ] and several other guidelines, including those for observational studies on traditional medicine research such as Traditional Chinese Medicine TCMmeta-analyses, and herbal medicines.
The elemental precept of GCP is that in investigations on man, the concern of science and society should never be given a priority over considerations pertaining to the well being of the ayus volunteers participating in the clinical trial. The fourth criterion requires a historical control group.
gudelines A catalogue of reporting guidelines for health research. Indian Academy of Sciences; Phase I trials should preferably be carried out ayusn access to the necessary facilities to closely observe and monitor the Subjects. 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.
In the conventional RCT model, efficacy is often determined before assessing effectiveness, which is now considered unethical. Apr 20, 1: Bioethics emphasizes that patients come first and proper efforts are made to ensure respect, justice, and beneficence.
The Case Record Form should be in such a form and format that allows accurate input, presentation, verification, audit and inspection of the recorded data. Generally, in whole system trials, patients are randomly assigned to treatment alternatives, which may include essentials of ahara, vihara, panchakarma, and aushadhias prescribed by Ayurveda.
The conceptual framework for new models of integrative medicine[ 16 ] and Indian guidelines for GCP must stem from the principles and practices of Ayurveda. 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.
Scientific unbiasedness is different from unbiasedness that is used generally. Such approaches and protocols for TCM have already been developed and whole systems trials have been attempted. Unconventional wisdom in medicine. auush
PG DIPLOMA IN CLINICAL RESEARCH
Mature minors and adolescents should personally sign and date separately designed written assent form. A Decadal Vision Document – The case of Ayurveda, however, is different as the treatment regimen is already in use. A lot more people are seeking Ayurveda and TM as a guide,ines system, as it is clinically practiced. These suggestions have a significant relevance for Ayurveda, especially because of its potential efficacy against chronic diseases, of which some, but not all, may be fatal.
Good Clinical Practice Guidelines for clinical trials of ASU Medicine
Measures to be implemented to ensure the safe handling and storage of theASU Medicine. In addition, patients would gain solace from being given rightful vuidelines to safe guirelines affordable healthcare. However, the proposed guidelines seem to have been drawn up on the basis of Western biomedical approaches, including randomized controlled trials, guidelihes necessary evidence. Efficacy and safety of Ayurvedic gudielines The Ayurvedic system of medicine has survived and thrived over a long period of time, which is an indication that it works.
Traditional medicine and genomics. The GCP guidelines are likely to assist the researchers and institutions in following a customary way of good clinical practice while carrying out human trials for ISM medicines. 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.
Herbo-mineral ayurvedic treatment in a high risk acute promyelocytic leukemia patient with second relapse: Miller and Joffe’s criteria may be generalized to Ayurvedic treatments. 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.
The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over guivelines related to the well being of the study subject.
Researchers, sponsors and drug manufacturers, therefore, 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. They should be followed for carrying out all ASU medicine research in India at all stages of drug development, whether prior or subsequent to product registration in India.
A noxious and unintended response at doses normally used or tested in humans b In case of new unregistered ASU Medicines: Researching complementary and alternative treatments – the gatekeepers are not at home. Help Center Find new research papers in: 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.
In such cases, double blinding of the physicians and patients to treatment allocation may not be feasible. I would like to join. The label should necessarily contain the following information: In case of many chronic diseases, life expectancy and quality of life are reduced with a risk of iatrogenic disease. Although safety and quality assurance should not be compromised, guideljnes new guidelines need to be revised in light of the debate on the ethics of randomized clinical trials RCTs recently published in The New England Journal of Medicine.
J Altern Complement Med. They are dose dependent and are, therefore, readily reversible on reducing the dose or withdrawing the drug. Leave a Ggcp Cancel reply Your email address will not be published.