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
Parallel
Berberine Phytosome (Sophy®)
Dietary supplementBerberine 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
BehavioralParticipants 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.
Change in Ferriman-Gallwey Score (Hirsutism)
Assessment of change in hirsutism severity using the Ferriman-Gallwey scoring system, which evaluates terminal hair growth in nine body areas. Scores range from 0 to 36, with higher scores indicating more severe hirsutism.
Change in Cardiff Acne Disability Index (CADI) Score
Assessment of change in acne-related quality of life using the Cardiff Acne Disability Index (CADI), a validated 5-item questionnaire evaluating the psychological and social impact of acne. Scores range from 0 to 15, with higher scores indicating greater impairment.
Change in Body Mass Index (BMI)
Assessment of change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Assessment of the change in insulin resistance measured by the HOMA-IR index calculated from fasting glucose and fasting insulin concentrations.
Change in Waist Circumference
Assessment of changes in waist circumference as a marker of central adiposity.
Change in Blood Pressure
Assessment of changes in systolic and diastolic blood pressure measured using standard clinical procedures.
Change in Global Acne Grading System (GAGS) Score
Assessment of acne severity using the Global Acne Grading System (GAGS).
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
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