Clinical Trial Protocol – Development and Implementation

Protocol is a document that describes how a clinical trial will be conducted (the objective(s), design,
methodology, statistical considerations and organization of a clinical trial) and ensures the safety of
the trial subjects and integrity of the data collected. It provides a structured framework to
individuals conducting the study, serves as the basis for trial registration, and facilitates study
appraisal by participants and external reviewers, including Ethics Committees (ECs), funding agencies
and journal editors.

This document covers various aspects of clinical trial protocols starting from defining objectives up
to dissemination of results along with appropriate examples applicable in AYUSH context. AYUSH
interventions are multi-targeted and can prove useful at various for prophylaxis of those not yet
affected, treatment of active COVID-19 cases and management of recovery stage. Further the trials
can evaluate AYUSH interventions as an add-on to conventional care or as stand-alone treatment.
They can be conducted on a single drug or formulation from AYUSH system or using whole system
approach (wherein holistic approach of AYUSH system is given due consideration). This document
has considered clinical trials with all these broad aims. It is expected that the document will help
designing better quality clinical trials for investigating AYUSH interventions.

The document refers related published guidelines on this topic and is based on scientific knowledge
and experience of the Task force members. The document also includes reports compiled by various
working groups under the Task Force, scientific deliberations and discussions during the meetings of
these working groups. It also provides sample protocols and Case Record Forms (CRFs) for various
trials that can be planned with AYUSH interventions (Refer Annexures 11), which are developed by
the members of the Task Force