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

Liaquat University of Medical & Health Sciences

Status: Not yet enrolling

Conditions: Polycystic Ovary Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07465575

53_9dicembre2022_Berberine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Berberine Phytosome (Inositol-Naïve)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Berberine Phytosome (Sophy®)

Behavioral: Lifestyle Advice

Berberine Phytosome + Inositol

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Berberine Phytosome (Sophy®)

Behavioral: Lifestyle Advice

Lifestyle Advice Only (Control)

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle Advice