Raj, Jeffrey Pradeep
Mani, Thenmozhi
Joy, Melvin
Pandit, Sukant
Godbole, Charuta
Bendkhale, Shital
Soni, Dhruve
Lakshmanan, Jeyaseelan
Gogtay, Nithya Jaideep
Funding for this research was provided by:
Manipal Academy of Higher Education, Manipal
Article History
Received: 13 July 2024
Accepted: 12 November 2025
First Online: 30 December 2025
Declarations
:
: The study was approved by the Institutional Ethics Committee (EC/OA-135/2021) and was also registered with the Clinical Trials Registry of India (CTRI) prospectively (CTRI/2021/09/036631) on 20/09/2021. It was conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Good Clinical Practice (GCP) – R2 (2018, Maryland, USA) and the Indian Council of Medical Research’s National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017, New Delhi, India). Written informed consent was obtained electronically from all potential participants and confidentiality maintained using unique identifiers.
: All authors have approved the final version of the manuscript being submitted and consent for publication.
: The authors declare no competing interests.