Clinical trial · Interventional
Berberine and Polycystic Ovary Syndrome
Berberine is an Effective Insulin Sensitizer and Improves Homeostasis of Metabolic and Hormonal Disorders in Women With Polycystic Ovary Syndrome: a Novel Treatment Strategy for 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)
Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Berberine | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Berberine | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Berberine
- description
- 2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
- interventionNames
- Dietary Supplement: Berberine
Primary outcomes (1)
- measure
- Changes on insulin resistance
- timeFrame
- Changes from baseline insulin resistance at 8 weeks
- description
- Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2.4
Secondary outcomes (17)
- measure
- Changes on inflammation
- timeFrame
- Changes from baseline inflammation at 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2) * newly detected Polycystic Ovary Syndrome Exclusion Criteria: * any concomitant medication * presence of liver, renal and thyroid disease * smoking * drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
References
Publications (0)
Data not yet available