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Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)
Sponsor: Liaquat University of Medical & Health Sciences
Summary
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.
Official title: Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-03-16
Completion Date
2027-03-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Berberine Phytosome (Sophy®)
Berberine phytosome administered orally at a dose of 550 mg once daily for 12 weeks. The formulation used in this study is Sophy® (PharmExtracta S.p.A., Italy), a nutraceutical preparation containing berberine designed to improve bioavailability.
Lifestyle Advice
Participants receive standardized lifestyle advice including dietary recommendations based on a Mediterranean diet and encouragement of regular physical activity such as brisk walking or cycling for approximately 30 minutes, three to five times per week.
Locations (1)
University of Urbino Carlo Bo
Urbino, Italy