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Authors
Sabah, Saleem https://orcid.org/0009-0008-4752-3120
Shobana, Krishnakumar https://orcid.org/0000-0002-2840-749X
Mitthra, Suresh https://orcid.org/0000-0003-3613-429X
Madhubala, Manavalan Madhana https://orcid.org/0000-0003-4220-264X
Venkatesh, Kondas Vijay https://orcid.org/0000-0002-9660-1817
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Funding
Funding for this research was provided by:
Indian Council of Medical Research (2023-13439)
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Article History
Received: 29 March 2025
Accepted: 17 January 2026
First Online: 4 February 2026
Declarations
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: None of the authors have any conflict of interest. The authors are solely responsible for the content and writing of the paper. The authors have no affiliation with or involvement in any organization or entity with any financial or non-financial interest in the subject matter or materials discussed in this manuscript.
: This randomized clinical trial was approved by the Institutional Ethical Committee of SRM Medical College Hospital and Research Centre with reference number (SRMIEC-ST0923-707) with approval dated 28/10/2023. The authors certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The trial was submitted for registration in the Clinical Trial Registry of India (CTRI) in October 2023 prior to participant enrollment; however, the formal registration number was issued on 30/12/2024 (CTRI/2024/12/078719), resulting in retrospective registration. Written informed consent was obtained from all the participants. The study complied with the CONSORT guidelines. The details of randomization and participant allocation are provided in the CONSORT flow diagram.
