This multicenter, randomized, controlled clinical trial aims to evaluate the effectiveness of berberine phytosome supplementation in improving signs and symptoms associated with polycystic ovary syndrome (PCOS). Women presenting with clinical features suggestive of PCOS, including hirsutism, acne, menstrual irregularities, and overweight, will be enrolled.
Participants will be randomly assigned to one of three groups: (1) berberine phytosome supplementation in women not previously taking inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, or (3) a control group receiving lifestyle advice without supplementation. The intervention will consist of berberine phytosome 550 mg once daily for 12 weeks.
The study will evaluate changes in clinical manifestations associated with hyperandrogenism and metabolic dysfunction, including hirsutism, acne severity, body mass index, and metabolic parameters. The results will provide evidence on the potential role of berberine phytosome supplementation in improving clinical manifestations related to PCOS.
Women aged 18-40 years
Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
Body mass index (BMI) ≥ 25 kg/m²
Evidence of insulin resistance (HOMA-IR above normal range)
Pregnancy or breastfeeding
Use of insulin-sensitizing drugs (e.g., metformin) within the previous 3 months
Current hormonal therapy including oral contraceptives or anti-androgens
Diagnosis of diabetes mellitus
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator