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Can a plant compound tame PCOS symptoms?

NCT ID NCT07465575

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 40 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. 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

  • University of Urbino Carlo Bo

    Urbino, Italy

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