Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome : a Double-blind, Randomized and Placebo-controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Ovulation rate
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Bushen Huatan Decoction) in women 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The diagnosis of PCOS is based on the Rotterdam criteria.
- •Meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in TCM theory.
- •women aged 18-40 years without fertility requirements.
- •A willingness to undergo this treatment plan.
排除标准
- •Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
- •Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
- •Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
- •Suspected Cushing's syndrome.
- •Adrenal or ovarian tumors secreting androgen.
- •Poorly controlled type II diabetes.
- •Pregnancy or lactation.
- •Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
- •Those who had taken hormones or other drugs during the previous 3 months.
- •Acute heart, liver, kidney or blood diseases.
研究组 & 干预措施
Therapy group
干预措施: Bushen Huatan Decoction (Drug)
Control group
干预措施: Placebo (Drug)
结局指标
主要结局
Ovulation rate
时间窗: 3 months
Ovulation rate in each group during the study period
次要结局
未报告次要终点
研究者
Ruining Liang
chief physician
Jiangxi University of Traditional Chinese Medicine