Berberine Phytosome for Improved PCOS Symptoms and Signs
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.
Berberine Phytosome (Sophy®)
+ Lifestyle Advice
Urogenital Diseases+10
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorStudy 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