Can a plant compound tame PCOS symptoms?
NCT ID NCT07465575
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a daily berberine supplement (550 mg) can improve PCOS symptoms like excess hair growth, acne, and weight in 150 women aged 18-40. Participants are split into three groups: those not taking inositol, those already on inositol, and a control group receiving only lifestyle advice. The trial lasts 12 weeks and measures changes in hair scores, acne impact, and body mass index.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- berberine phytosome (a dietary supplement)
- What this could lead to
- If it works, this could point toward a natural supplement option to help manage PCOS symptoms like excess hair, acne, and weight gain.
- What could go wrong
- This is a small, early-stage trial with only 150 participants over 12 weeks. The supplement may not work better than lifestyle changes alone, and results may not apply to all women with PCOS.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Urbino Carlo Bo
Urbino, Italy
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