NEW DELHI / CHENNAI: The Proven Code announces that its commercially available Berberine 500 mg capsules are being evaluated against metformin in an investigator-initiated clinical study at SRM. The trial will assess efficacy and safety in women with polycystic ovary syndrome (PCOS), with the brand supplying the same finished-pack product available to consumers.
Titled “Efficacy and Safety of Berberine in Polycystic Ovary Syndrome: A Randomized Controlled Trial,” the study is registered with the Clinical Trials Registry – India under CTRI/2026/04/107414.
The research is led by Principal Investigator Dr. V. Periswaran, Pharm.D., of SRM College of Pharmacy, SRM Institute of Science and Technology. SRM Medical College Hospital & Research Centre is the clinical site.
The product consumers buy enters clinical evaluation
For The Proven Code, the study places its commercial product directly into an academic clinical research setting. The capsules supplied to investigators are provided in commercially available finished-pack form, making the identity of the product under evaluation clear.
“The study places the commercially available product itself at the centre of an independent clinical evaluation.”
Berberine and metformin compared over 12 weeks
The prospective, randomized, open-label, comparative clinical study assigns participants to receive berberine 500 mg twice daily for 12 weeks or metformin 500 mg twice daily for 12 weeks.
The primary objective is to compare improvement in insulin resistance in women with PCOS. Researchers will also evaluate safety and hormonal parameters, alongside outcomes including body weight, BMI, waist-to-hip ratio, menstrual regularity, ovulatory function, lipid profile, glycaemic parameters and hyperandrogenism.
The comparison is a research question, not a clinical finding. Registration does not establish efficacy or safety, or demonstrate that berberine is equivalent to, superior to or a replacement for metformin.
Independent research with product support from The Proven Code
The study is investigator-initiated and academically independent. The Proven Code provides the Berberine 500 mg capsules as in-kind support, together with relevant batch and quality documentation. The company has no role in recruitment, data collection, analysis, interpretation, publication decisions or conclusions.
Scientific and clinical decisions remain with the investigators and institution. Any claims arising from the trial must be supported by the completed study data and their analysis and reporting.
By supplying its commercial product for independent evaluation, The Proven Code is taking a concrete step towards building evidence specific to the capsules it sells. The next milestone is the completion and reporting of the study, when the findings can be assessed on their merits. Until then, the significance of this development is the commitment to evaluating the finished product, with the outcome left to the research.
About The Proven Code
The Proven Code is an Indian nutraceutical brand built on a simple principle: health claims should be supported by evidence people can verify. The brand develops supplements using branded, standardized ingredients supported by published human research, with an emphasis on purity, independent testing and traceable sourcing. Its formulations disclose active ingredient amounts without proprietary blends, helping consumers understand what they are taking and the research behind it. Through transparent product information and support for independent clinical evaluation, The Proven Code aims to make verifiable evidence a standard of everyday supplementation. Its guiding philosophy is “Every Claim. Proven.”
Study information
- Study Title: Efficacy and Safety of Berberine in Polycystic Ovary Syndrome: A Randomized Controlled Trial
- CTRI Registration: CTRI/2026/04/107414
- Principal Investigator: Dr. V. Periswaran, Pharm.D.
- Institution: SRM College of Pharmacy, SRM Institute of Science and Technology
- Clinical Site: SRM Medical College Hospital & Research Centre
- Study Design: Prospective, randomized, open-label, comparative clinical study
- Intervention: Berberine 500 mg twice daily for 12 weeks
- Comparator: Metformin 500 mg twice daily for 12 weeks
- Study Product: The Proven Code commercially available finished-pack Berberine 500 mg capsules
- Research Governance: Investigator-initiated and academically independent
