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Berberine Phytosome for Improved PCOS Symptoms and Signs

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Study Aim

This study aims to evaluate the effectiveness of Berberine Phytosome in improving symptoms and signs of PCOS, primarily by measuring changes in insulin resistance through the HOMA-IR index after 12 weeks of treatment.

What is being tested

Berberine Phytosome (Sophy®)

+ Lifestyle Advice

Dietary SupplementBehavioral
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Adnexal Diseases

From 18 to 40 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorLiaquat University of Medical & Health Sciences
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 16, 2026

Actual date on which the first participant was enrolled.

This study focuses on the effectiveness of Berberine Phytosome in managing Polycystic Ovary Syndrome (PCOS), a common hormonal disorder affecting women of childbearing age. PCOS often leads to irregular periods, acne, excess hair growth, and weight gain, and is linked to insulin resistance. Berberine Phytosome is a plant-derived supplement designed to improve insulin sensitivity and metabolic regulation. The study involves 150 women aged 18-40 with PCOS symptoms, divided into three groups. Two groups will receive Berberine Phytosome, one with no prior inositol use, and the other with at least three months of inositol use. The third group serves as a control, receiving only lifestyle advice. The study aims to understand if Berberine Phytosome can help manage PCOS symptoms, potentially improving care for those affected by this condition. Participants in the Berberine Phytosome groups will take a 550 mg oral supplement daily for 12 weeks. All participants, including the control group, will receive lifestyle recommendations such as dietary advice and encouragement for regular physical activity. The study will measure changes in various clinical parameters, including acne severity, body mass index, and insulin resistance. It will also assess metabolic parameters like waist circumference and blood pressure, as well as quality of life. Safety will be monitored through tracking any adverse events during the study period. The results will help determine the potential role of Berberine Phytosome in managing PCOS symptoms.

Official TitleEffectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial
Principal SponsorLiaquat University of Medical & Health Sciences
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCystsEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersNeoplasmsOvarian CystsOvarian DiseasesPolycystic Ovary SyndromeFemale Urogenital Diseases

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in women who have not previously taken inositol. Participants also receive lifestyle advice including dietary guidance and encouragement of regular physical activity.

Group II

Experimental
Participants who have been taking inositol (myo-inositol or D-chiro-inositol) for at least three months receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in addition to ongoing lifestyle advice including dietary guidance and regular physical activity.

Group III

Active Comparator
Participants receive lifestyle advice including dietary guidance and recommendations for increased physical activity without berberine phytosome supplementation during the 12-week study period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Urbino Carlo Bo

Urbino, ItalyOpen University of Urbino Carlo Bo in Google Maps
Recruiting soonOne Study Center