Clinical trial · Interventional
Treatment Benefits of Berberine Supplementation for Women With PCOS
Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Berberine is a plant alkaloid, reportedly possesses a wide range of pharmacological activities, including anti-obesity and anti-dyslipidemia. Berberine is an effective insulin sensitizer and has a comparable activity to MET in reducing IR. A large body of evidence suggest that Berberine dietary supplementation helps in improvement of symptoms associated with Polycystic Ovary Syndrome (PCOS). The purpose of this study is to investigate the treatment benefits of Berberine in women with PCOS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Berberine | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Berberine arm
- description
- Participants in this group will receive an oral 550 mg Berberine supplement tablet BDS for 3-months as an add-on to the changes in the diet/life-style for 3-months. The changes in the diet/life-style include limiting fat and carbohydrate intake and improve dietary behavior without the application of a calorie-restricted diet program. Exercise will also be recommended to include 30 min/day of moderate to intense activity.
- interventionNames
- Dietary Supplement: Berberine
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Participants in this group will undergo changes in their diet/life-style.
Primary outcomes (2)
- measure
- Effect of Berberine on fasting blood glucose
- timeFrame
- up to 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged between 18 and 45 years 2. PCOS diagnosis as per the Rotterdam Criteria (any two of the following features: * Irregular periods (allso called oligomenorrea) or no periods (amenorrhea), * Higher levels of andregens present in the blood (hyperandrogenism), or physical characteristics of elevated andregen levels such as acne, male-pattern balding, or excess hair growth on face, chin, or body * Polycystic ovaries visible on an ultrasound 3. Normal, over-weight, and obese class I women (BMI 18.5 - 29.9 kg/m2, BMI cut-off as per the Asian criteria) 4. With no desire for pregnancy within 6 months 5. Able to give informed written consent Exclusion Criteria: 1. Women who are currently taking or have teken in the last three months medications known to alter insulin physiology, oral contraceptives, ovulation induction drugs, anti- obesity or cholestrol lowering drugs, or any supplement known to interfere with insulin and androgen metabolism such as inositols, curcumin, lipoic acid, cinnamon, gymnemic and other botanical extracts. 2. Women undergoing in vitro fertilization treatment. 3. Women diagnosed with lateonset congenital adrenal hyperplasia (17-OH progestrone), thyroid disorders, hyperprolactinemia, diabetes mellitus and ODST. 4. Presence of liver, or renal disease 5. Pregnant or lactating or menopause women
References
Publications (1)
- DERIVEDDi Pierro F, Sultana R, Eusaph AZ, Abrar S, Bugti M, Afridi F, Farooq U, Iqtadar S, Ghauri F, Makhduma S, Nourin S, Kanwal A, Bano A, Bugti AA, Mureed S, Ghazal A, Irshad R, Recchia M, Bertuccioli A, Putignano P, Riva A, Guasti L, Zerbinati N, Khan A. Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial. Front Pharmacol. 2023 Nov 21;14:1269605. doi: 10.3389/fphar.2023.1269605. eCollection 2023. PMID 38074133