Berberine phytosome supplement for symptoms of polycystic ovary syndrome
Tests berberine phytosome supplements in women with polycystic ovary syndrome symptoms.
Plain-language title generated from the registry record
Registry title: Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)
Key facts
- Where
- Urbino, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18-40 with polycystic ovary syndrome (PCOS), overweight and with insulin resistance. It tests berberine phytosome 550 mg once daily for 12 weeks.
- Age
- 18-40 years
- Sex
- Women only
- Disease stage
- PCOS diagnosed by the Rotterdam criteria, body mass index (BMI) of 25 kg/m² or more, and insulin resistance (HOMA-IR above the normal range).
- Earlier treatment
- No insulin-sensitizing drugs such as metformin in the previous 3 months. No berberine supplements in the previous 3 months. No current hormonal therapy.
- Biomarker or test result
- HOMA-IR above the normal range (a sign of insulin resistance).
Main reasons for not taking part
- Pregnant or breastfeeding
- Diabetes
- Known liver, kidney, heart or other hormone disease besides PCOS
- Taking hormonal therapy such as birth control pills or anti-androgens
- Known allergy to berberine or related compounds
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Source: NCT07465575, who can take part
Where in Italy
- University of Urbino Carlo BoUrbino, ItalyContact: Prof. Davide, Sisti, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Liaquat University of Medical & Health Sciences
- Trial code
- NCT07465575
- Record updated
- 19 March 2026
- Original description
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.Read full original descriptionShow less
Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial
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.
Inclusion: 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: 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; Diagnosis of diabetes mellitus; Known liver, renal, cardiovascular, or endocrine diseases other than PCOS; Known hypersensitivity to berberine or related compounds; Pregnancy or breastfeeding.