NCT07465575Not yet recruiting
Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)
Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 6 Mar 2026
- Start date
- 16 Mar 2026
- Primary completion date
- 19 Feb 2027
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- NCT number
- NCT07465575
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 16 Mar 2026 to the primary completion date, 19 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of insulin-sensitizing drugs (e.g., metformin) within the previous 3 months
- Current hormonal therapy including oral contraceptives or anti-androgens
- Use of berberine-containing supplements within the previous 3 months
Other illness
- Diagnosis of diabetes mellitus
- Known liver, renal, cardiovascular, or endocrine diseases other than PCOS
- Known hypersensitivity to berberine or related compounds
Other
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Urbino Carlo Bo Coordinator of this site? Confirm its status | Urbino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.