Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Cardiff Acne Disability Index (CADI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Berberine Phytosome (Sophy®) (Dietary Supplement)
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.
干预措施: Lifestyle Advice (Behavioral)
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.
干预措施: Berberine Phytosome (Sophy®) (Dietary Supplement)
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.
干预措施: Lifestyle Advice (Behavioral)
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.
干预措施: Lifestyle Advice (Behavioral)
结局指标
主要结局
Change in Cardiff Acne Disability Index (CADI) Score
时间窗: 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.
Change in Ferriman-Gallwey Score (Hirsutism)
时间窗: 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.
Change in Body Mass Index (BMI)
时间窗: 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).
次要结局
- Change in Blood Pressure(Baseline to Week 12)
- Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)(Baseline to Week 12)
- Change in Waist Circumference(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)