NCT07465575

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 6, 2026

Last Update Submit

March 16, 2026

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

  • Change in Ferriman-Gallwey Score (Hirsutism)

    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

    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)

    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 Outcomes (5)

  • Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)

    Baseline to Week 12

  • Change in Waist Circumference

    Baseline to Week 12

  • Change in Blood Pressure

    Baseline to Week 12

  • Change in Global Acne Grading System (GAGS) Score

    Baseline to Week 12

  • Change in Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ)

    Baseline to Week 12

Study Arms (3)

Berberine Phytosome (Inositol-Naïve)

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.

Dietary Supplement: Berberine Phytosome (Sophy®)Behavioral: Lifestyle Advice

Berberine Phytosome + Inositol

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.

Dietary Supplement: Berberine Phytosome (Sophy®)Behavioral: Lifestyle Advice

Lifestyle Advice Only (Control)

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.

Behavioral: Lifestyle Advice

Interventions

Berberine Phytosome (Sophy®)DIETARY_SUPPLEMENT

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.

Also known as: Sophy® (PharmExtracta S.p.A., Italy)
Berberine Phytosome (Inositol-Naïve)Berberine Phytosome + Inositol
Lifestyle AdviceBEHAVIORAL

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.

Berberine Phytosome (Inositol-Naïve)Berberine Phytosome + InositolLifestyle Advice Only (Control)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPCOS is a condition of females only.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Urbino Carlo Bo

Urbino, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) berberine phytosome supplementation in women who have never taken inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, and (3) a control group receiving lifestyle advice without supplementation. The intervention duration will be 12 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

February 19, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

IT(1)