Document is current

Article History

Received: 17 June 2025

Accepted: 7 April 2026

First Online: 9 May 2026

Declarations

:

: The trial complies with approved protocol, ICH-GCP guidelines, Indian GCP, New Drugs and Clinical Trial Rules, 2019, and all applicable regulatory requirements. The study commenced after receiving approval from a CDSCO-registered Ethics Committee (EC) for protocol, informed consent form (ICF), and participant information sheet. The study is approved by CDSCO, CT NOC No. is CT/SND/27/2023, protocol number DESI.23.001, registered on 12 June 2023. All participants will provide written informed consent before any trial-related procedures. For illiterate participants, the consent process will involve a verbal explanation in a language understood by the participant, a thumb impression, and the signature of an impartial witness. Participants will receive a copy of the signed consent form. Medical records may be accessed by authorized sponsor representatives, EC members, and regulatory inspectors for monitoring and audit purposes. Amendments to the consent documents will require EC approval and re-consent of affected participants, as applicable.

: This is the study protocol manuscript and no patient data is submitted as a part of this document. Consent for publication of results is being obtained at the time of obtaining informed consent during the enrollment process. The patient information material and informed consent form will be available from ICMR and Zydus Lifesciences Limited upon reasonable request.

: The following individuals are employed by and have affiliations with the organizations listed: MG, GK, SR, SK, and AM: Indian Council of Medical Research (ICMR), co-funder of the study. DP, KK, and SS: Zydus Lifesciences Limited, co-funder of the study.