Parekh, Rajesh
Hammond, Billy R. Jr.
Chandradhara, Divya
Article History
Received: 6 December 2023
Accepted: 12 January 2024
First Online: 16 February 2024
Declaration
:
: Rajesh Parekh is affiliated to the clinical study site, Sanjeevani Netralaya, where the study was conducted. Billy R. Hammond Jr is a professor at the University of Georgia, Athens and supported as a consultant for the sponsor in study and manuscript development. Divya Chandradhara is an employee of Bioagile Therapeutics Pvt. Ltd., the Contract Research Organization contracted to conduct the presented study.
: Institutional ethics approval was obtained from Pranav Diabetes Center Ethics Committee, Bengaluru, Karnataka, India. This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with the International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, as well as in strict compliance with the “The New Drugs and Clinical Trial Rules- 2019”, the Ministry of Health and the Government of India at all stages of the trial for adherence to protocol and compliance with ethical and regulatory guidelines. Voluntary consent was obtained in written from all the study participants before commencing any study related activities. The EC was duly apprised of the progress and updates of the trial at regular intervals as per prescribed guidelines.