Aug 11, 2012

An info for Ayurveda PG & PhD Scholars about the Clinical Trials Registry - India

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. Unfortunately, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials abandoned or are not published due to "negative" or equivocal results. However, this tendency for availability of only selective information from the myriad clinical trials conducted is not commensurate with the practice of "evidence-based medicine". Today, world over, a need has been felt on the imperative for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. And this would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry. Registration of trials will ensure transparency, accountability and accessibility of clinical trials.
The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (NIMS), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 ( Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) ( Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH ( is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Being a Primary Register of the International Clinical Trials Registry Platform (ICTRP) (, registered trials are freely searchable both from the WHO's search portal, the ICTRP as well as from the CTRI (
The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered, i.e. before the enrollment of the first participant.
While the mission of the CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant currently, trials where patient recruitment has started or even completed are also being registered. Post-marketing surveillance studies as well as BA/BE trials are also expected to be registered in the CTRI.

PG Thesis Registration
Trials being conducted as part of PG thesis should mention both student?s as well as Guide's name and full official address, including department. Co-guide name may also be included, if desired). Names should be included in Contact Person details after mutual agreement on division of responsibilities. Verification is sought by email from all trial Contact Persons, except the trial Registrant

For frequently asked questions about CTRI registration, please visit

All the PG and PhD scholars of Ayurveda doing clinical studies must consider registering their works in CTRI for more authenticity of their works, in turn for evidence basis of Ayurveda and registration is not at all a complicated procedure. It is being practiced in IPGT & RA, GAU, Jamnagar.


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