|Year : 2021 | Volume
| Issue : 3 | Page : 99-101
Ayurveda dataset items in clinical trial registry of India: An impetus for research in Ayurveda
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India, New Delhi, India
|Date of Submission||29-Dec-2021|
|Date of Acceptance||11-Jan-2022|
|Date of Web Publication||22-Mar-2022|
Dr. Narayanam Srikanth
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India, New Delhi.
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Srikanth N. Ayurveda dataset items in clinical trial registry of India: An impetus for research in Ayurveda. J Res Ayurvedic Sci 2021;5:99-101
|How to cite this URL:|
Srikanth N. Ayurveda dataset items in clinical trial registry of India: An impetus for research in Ayurveda. J Res Ayurvedic Sci [serial online] 2021 [cited 2022 Aug 18];5:99-101. Available from: http://www.jrasccras.com/text.asp?2021/5/3/99/340287
Clinical trials form a major part of medical research and all clinical trials being conducted should be registered in WHO’s International Clinical Trial Registry Platform (ICTRP). The Clinical Trials Registry – India (CTRI) was launched on July 20, 2007 and is managed by the ICMR – National Institute of Medical Statistics (NIMS), New Delhi. It is a web-based platform (available at www.ctri.nic.in) for registering clinical studies that are being conducted in India. CTRI is a primary registry of ICTRP and trials registered in CTRI become part of the global pool clinical trial data, which can be searchable and viewable from the ICTRP as well. All clinical studies involving human participants and requiring ethics approval are registered in the CTRI, prior to participant enrollment, the CTRI undertakes only prospective registration. Studies registered include interventional trials, observational, BA/BE, and PMS studies from all branches of medical research including those from AYUSH, dentistry, and PG thesis-based studies. Although the dataset items for all types of studies are uniform, recently the NIMS, in collaboration with CCRAS has introduced customized dataset items for Ayurveda trials. This is expected to help in collecting more effective and relevant Ayurveda system-specific information and in turn generate evidence, thereby raising the standard of research in Ayurveda.
The addition of Dataset items specific to Ayurveda has been done keeping the core structure of the registration form as such and by adding on the details pertaining to Ayurveda, wherever required. Thus, modifications have been made in the sections “a. Health Condition”, wherein disease names in Ayurveda terminologies along with 3866 morbidity codes incorporated from the National Ayush Morbidity and Standardized Terminologies Electronic Portal (NAMASTE Portal) of the Ministry of Ayush, Government of India for entering of the morbidity condition on which the trial being registered is being conducted; and “b. Intervention and Comparator”, where three subsections of Drug, Procedure and Lifestyle have been added wherein names of the Ayurveda drugs, procedures or any lifestyle modifications (including Pathya/Apathya) suggested as applicable to the said trial can be entered. Among the three, the procedures can be selected from dropdown menu of 388 procedures and drug and lifestyle can be added as text input; Information of the drug(s) used in the trial along with name, reference (if classical drug), route of administration, dosage form, dose, dose unit, frequency, Bhaishajya Kala (time of medicine administration), duration, Anupana/Sahapana (vehicle) and any additional information; Information of the procedure(s) used in the trial along with reference and details of the same can be entered.
This initiative enables Ayurveda clinical trials to be registered with details in Ayurveda terminologies and will benefit that enables the user to enter comprehensive details regarding the trial, which can further be retrieved by the users; removes instances of ambiguities, missing information, and non-standardization of collected data; and the data collected has the potential to be queried in various ways to do analytics on the various trials undertaken in Ayurveda in future, for example, the number of trials on specific procedure or number of trials involving specific drugs and dosage forms.
Thus, the addition of Ayurveda dataset in the CTRI will certainly strengthen the field of clinical research in Ayurveda by providing domain-specific fields for data input, collection, retrieval, and analysis.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.