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Clinical Trials in Italy / NCT07465575
Starting soon Not applicable

Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)

NCT07465575 · tracked via the Priya Life Science Italy tracker
Sponsor
Liaquat University of Medical & Health Sciences
Phase
Not applicable
Started
2026-03-16
Last updated
2026-03-19

Condition(s) studied

Polycystic Ovary Syndrome

Investigational drug(s) / intervention(s)

Berberine Phytosome (Sophy®)Lifestyle Advice

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * 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) * Willingness to follow lifestyle recommendations including dietary advice and physical activity * Ability to provide written informed consent Exclusion Criteria: * 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 * Known liver, renal, cardiovascular, or endocrine diseases other than PCOS * Use of berberine-containing supplements within the previous 3 months * Known hypersensitivity to berberine or related compounds

Primary outcome measure(s)

  • Change in Ferriman-Gallwey Score (Hirsutism) — Baseline to Week 12
    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 — Baseline to Week 12
    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) — Baseline to Week 12
    Assessment of change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²).

Trial sites (1)

FacilityCityRegionStatus
University of Urbino Carlo Bo Urbino Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465575 on ClinicalTrials.gov ↗ ← All trials in Italy