Efficacy and safety of HIMABERB® Berberine on glycemic control in patients with prediabetes: double-blind, placebo-controlled, and randomized pilot trial.

"Declarations Consent for publicationNo individual’s data requring consent is presented in this manuscript. Informed consent and patient detailsInformed consent was given by all participants in this study. The work described was carried out by The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans. This study (approval no. SOA/IDS/IRB/2021−10) was approved by the Institutional Ethical Committee (IEC), IMS & SUM Hospital, Siksha ’O’ Anusandhan University, K−8 Kalinga Nagar. Bhubaneswar, Odisha−75003 (on May 17, 2021). The study protocol was registered at http://ctri.nic.in (CTRI/2021/12/038751, December 20, 2021). Conflict of interestThe authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Conflict of interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper."

"Funding This study was funded by Siksha O Anusandhan (Deemed to be University). No extramural sources funded this research."

"Trial registration http://ctri.nic.in(CTRI/2021/12/038751) (20/12/2021)."