Ramapalaniappan, Abiraamasundari
Loganathan, Vijayakrishnan
Morde, Abhijeet
Padigaru, Muralidhara
Patni, Paras
Joshua, Lincy
Thomas, Jestin V.
Article History
Received: 9 April 2025
Accepted: 20 June 2025
First Online: 1 August 2025
Declarations
:
: Muralidhara Padigaru, Abhijeet Morde, and Paras Patni are employees of OmniActive Health Technologies Limited. R Abiraamasundari, L Vijayakrishnan, Lincy Joshua, and Jestin V. Thomas declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
: Institutional ethics approval was obtained from ‘The Research Ethics Committee’ Coimbatore, 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 Family Welfare 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.