Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS) (NCT07465575) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)
Italy150 participantsStarted 2026-03-16
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Ferriman-Gallwey Score (Hirsutism)
Timeframe: Baseline to Week 12
2
Change in Cardiff Acne Disability Index (CADI) Score
Timeframe: Baseline to Week 12
3
Change in Body Mass Index (BMI)
Timeframe: Baseline to Week 12
Trial details
NCT IDNCT07465575
SponsorLiaquat University of Medical & Health Sciences