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| Name | Class |
|---|---|
| University of Urbino "Carlo Bo" | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
PCOS is a condition of females only.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Urbino Carlo Bo | Urbino | Italy |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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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.
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| Lifestyle Advice | Behavioral | 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. |
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Assessment of changes in waist circumference as a marker of central adiposity. |
| Baseline to Week 12 |
| Change in Blood Pressure | 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 | 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) | Assessment of changes in health-related quality of life using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ). | Baseline to Week 12 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |