Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)

March 16, 2026 updated by: Liaquat University of Medical & Health Sciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder affecting women of reproductive age and characterized by hyperandrogenism, menstrual irregularities, metabolic alterations, and dermatological manifestations such as acne and hirsutism. These clinical manifestations are often associated with insulin resistance and metabolic dysregulation.

Berberine is an isoquinoline alkaloid derived from several medicinal plants, including Berberis species, and has been reported to exert insulin-sensitizing, lipid-lowering, and metabolic regulatory effects. However, conventional berberine formulations have limited intestinal absorption and low systemic bioavailability. Berberine phytosome is a formulation designed to improve the bioavailability of berberine.

This study is designed as a prospective, multicenter, randomized, controlled clinical trial enrolling 150 women aged 18-40 years presenting with clinical signs suggestive of PCOS. Participants will be randomized into three parallel groups: (1) berberine phytosome supplementation in women who have never taken inositol, (2) berberine phytosome supplementation in women who have been taking inositol for at least three months, and (3) a control group receiving lifestyle advice without supplementation.

The intervention will consist of oral berberine phytosome 550 mg once daily for 12 weeks. All participants will receive lifestyle recommendations including dietary advice and encouragement of regular physical activity.

Primary outcomes include changes in clinical parameters associated with hyperandrogenism and metabolic status, including hirsutism (Ferriman-Gallwey score), acne severity (Cardiff Acne Disability Index), and body mass index. Secondary outcomes include metabolic parameters such as the HOMA index, waist circumference, blood pressure, hormonal profiles, lipid parameters, and quality of life assessments.

Safety will be evaluated through monitoring of adverse events during the study period. The results of this trial will help clarify the potential role of berberine phytosome supplementation in the management of clinical manifestations associated with PCOS.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Berberine Phytosome (Inositol-Naïve)
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.
Dietary supplement: Berberine Phytosome (Sophy®)
Berberine phytosome administered orally at a dose of 550 mg once daily for 12 weeks. The formulation used in this study is Sophy® (PharmExtracta S.p.A., Italy), a nutraceutical preparation containing berberine designed to improve bioavailability.
Other Names:
  • Sophy® (PharmExtracta S.p.A., Italy)
Behavioral: Lifestyle Advice
Participants receive standardized lifestyle advice including dietary recommendations based on a Mediterranean diet and encouragement of regular physical activity such as brisk walking or cycling for approximately 30 minutes, three to five times per week.
Experimental: Berberine Phytosome + Inositol
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.
Dietary supplement: Berberine Phytosome (Sophy®)
Berberine phytosome administered orally at a dose of 550 mg once daily for 12 weeks. The formulation used in this study is Sophy® (PharmExtracta S.p.A., Italy), a nutraceutical preparation containing berberine designed to improve bioavailability.
Other Names:
  • Sophy® (PharmExtracta S.p.A., Italy)
Behavioral: Lifestyle Advice
Participants receive standardized lifestyle advice including dietary recommendations based on a Mediterranean diet and encouragement of regular physical activity such as brisk walking or cycling for approximately 30 minutes, three to five times per week.
Active Comparator: Lifestyle Advice Only (Control)
Participants receive lifestyle advice including dietary guidance and recommendations for increased physical activity without berberine phytosome supplementation during the 12-week study period.
Behavioral: Lifestyle Advice
Participants receive standardized lifestyle advice including dietary recommendations based on a Mediterranean diet and encouragement of regular physical activity such as brisk walking or cycling for approximately 30 minutes, three to five times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ferriman-Gallwey Score (Hirsutism)
Time Frame: Baseline to Week 12
Assessment of change in hirsutism severity using the Ferriman-Gallwey scoring system, which evaluates terminal hair growth in nine body areas. Scores range from 0 to 36, with higher scores indicating more severe hirsutism.
Baseline to Week 12
Change in Cardiff Acne Disability Index (CADI) Score
Time Frame: Baseline to Week 12
Assessment of change in acne-related quality of life using the Cardiff Acne Disability Index (CADI), a validated 5-item questionnaire evaluating the psychological and social impact of acne. Scores range from 0 to 15, with higher scores indicating greater impairment.
Baseline to Week 12
Change in Body Mass Index (BMI)
Time Frame: Baseline to Week 12
Assessment of change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Time Frame: Baseline to Week 12
Assessment of the change in insulin resistance measured by the HOMA-IR index calculated from fasting glucose and fasting insulin concentrations.
Baseline to Week 12
Change in Waist Circumference
Time Frame: Baseline to Week 12
Assessment of changes in waist circumference as a marker of central adiposity.
Baseline to Week 12
Change in Blood Pressure
Time Frame: Baseline to Week 12
Assessment of changes in systolic and diastolic blood pressure measured using standard clinical procedures.
Baseline to Week 12
Change in Global Acne Grading System (GAGS) Score
Time Frame: Baseline to Week 12
Assessment of acne severity using the Global Acne Grading System (GAGS).
Baseline to Week 12
Change in Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ)
Time Frame: Baseline to Week 12
Assessment of changes in health-related quality of life using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ).
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat University of Medical & Health Sciences

Collaborators

University of Urbino "Carlo Bo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

February 19, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53_9dicembre2022_Berberine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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