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Article History

Received: 3 September 2025

Accepted: 22 January 2026

First Online: 9 February 2026

Declarations

:

: The present study was conducted in compliance with the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, General Assembly, Seoul 2008), International Conference on Harmonization–Good Clinical Practice (ICH–GCP) — 2016, and Ethical Guidelines for Biomedical Research on Human Participants, 2006 (Indian Council of Medical Research, India). It was approved by an Independent Ethics Committee, the Harmony Ethical Research Committee (Reg. No.: ECR/1411/Inst/MH/2020), to safeguard the rights, safety, and well-being of all trial participants. The participants who provided voluntary, written informed consent were enrolled in the study. Vedic Lifesciences, Mumbai, India, monitored and audited the study to ensure the study protocol and ICH-GCP compliance. The study report conformed to the Consolidated Standard Reporting of Trials (CONSORT) guidelines.

: Not applicable.

: Erin McKinney and Jeremy Stewart were affiliated with Gaia Herbs during the conduct of the study. Rajesh Kewalramani served as both the principal investigator and as an author of this study, conducted under the supervision of Vedic Lifesciences. The authors declare no competing interests.