Ethical considerations
The study adhered to the guidelines set forth by the International Committee on Harmonization on Good Clinical Practice and followed the revised version of the Declaration of Helsinki. Approval for the study protocol was obtained from the institutional human ethics committee of SRM Medical College Hospital and Research Centre on March 25, 2022, with Ethics Clearance No: 8275/IEC/2022. The study is registered with the Clinical Trials Registry India (CTRI) under the reference number
