Effect of Berberine Supplementation on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effect of Berberine on fasting blood insulin
研究概览
简要总结
Berberine is a plant alkaloid, reportedly possesses a wide range of pharmacological activities, including anti-obesity and anti-dyslipidemia. Berberine is an effective insulin sensitizer and has a comparable activity to MET in reducing IR. A large body of evidence suggest that Berberine dietary supplementation helps in improvement of symptoms associated with Polycystic Ovary Syndrome (PCOS). The purpose of this study is to investigate the treatment benefits of Berberine in women with PCOS.
详细描述
Berberine (BBR) is an isoquinoline derivative alkaloid that occurs in several plants including Oregon grape, barberry, tree turmeric, goldenseal, yellowroot, Amur corktree, Chinese goldthread, prickly poppy and Californian poppy.
Berberine supplementation has been suggested to improve the symptoms associated with PCOS. Berberine;
Reduces Insulin Resistance Lowers Blood Sugar Levels Aids in Weight Loss Improves Cholesterol Levels Regulates Menstrual Cycles Reduces Inflammation Helps Restore Hormonal Balance Improves Fertility Helps Combat Depression Helps Fight Fatty Liver Disease Improves Body Composition
The present RCT is aimed to investigate the effect of Berberine on these symptoms associated with PCOS.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 45 years
- •PCOS diagnosis as per the Rotterdam Criteria (any two of the following features:
- •Irregular periods (allso called oligomenorrea) or no periods (amenorrhea),
- •Higher levels of andregens present in the blood (hyperandrogenism), or physical characteristics of elevated andregen levels such as acne, male-pattern balding, or excess hair growth on face, chin, or body
- •Polycystic ovaries visible on an ultrasound
- •Normal, over-weight, and obese class I women (BMI 18.5 - 29.9 kg/m2, BMI cut-off as per the Asian criteria)
- •With no desire for pregnancy within 6 months
- •Able to give informed written consent
排除标准
- •Women who are currently taking or have teken in the last three months medications known to alter insulin physiology, oral contraceptives, ovulation induction drugs, anti- obesity or cholestrol lowering drugs, or any supplement known to interfere with insulin and androgen metabolism such as inositols, curcumin, lipoic acid, cinnamon, gymnemic and other botanical extracts.
- •Women undergoing in vitro fertilization treatment.
- •Women diagnosed with lateonset congenital adrenal hyperplasia (17-OH progestrone), thyroid disorders, hyperprolactinemia, diabetes mellitus and ODST.
- •Presence of liver, or renal disease
- •Pregnant or lactating or menopause women
结局指标
主要结局
Effect of Berberine on fasting blood insulin
时间窗: up to 3 months
Effect of Berberine on fasting blood glucose
时间窗: up to 3 months
次要结局
- Effect of Berberine on fasting lipid metabolic profile(up to 3 months)
- Effect of Berberine on physical sign and symptoms associated with PCOS(up to 3 months)
- Effect of Berberine on hormonal profile(up to 3 months)
- Effect of Berberine on non-invasive markers of liver injury(up to 3 months)