A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 发起方
- Aijun Sun
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- symptoms
研究概览
简要总结
This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in adults women. One third of participants will receive Dingkundan capsules, one third of participants will receive Diane-35 Pills, and the another third will receive Dingkundan capsules and Diane-35 in combination.
详细描述
Dingkundan,Diane-35 each ameliorate PCOS, but they do so by different mechanisms. We generally treat PCOS patients without immediate fertility requirement by short-acting contraceptives,Diane-35 is one of the most commonly used drugs.
Dingkundan consists of multiple chinese herbs including ginseng,Panax notoginseng,deer antlers,Carthamus tinctorius L.,Radix Paeoniae Alba,prepared Radix Rehmanniae,Angelica etc., which gains widespread application in the treatment of gynecological diseases. Based on the characteristics above, we try to explore its clinical application value in PCOS and its biological mechanisms.
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
- 是
入选标准
- •Subject is a female between the age of 18 and
- •Subject diagnosed as PCOS by the 2003 Rotterdam criteria.
- •Subject provides written informed consent.
排除标准
- •Subject has other endocrine diseases,such as adrenal hyperplasias or tumor, androgen-secreting tumours, Cushing's syndrome,thyroid diseases and hyperprolactinemia.
- •Subject has received related medical or surgical treatment in the past 3 months.
- •Subject suffered from substance abuse or dependence(such as alcohol or drugs);
- •Subject is a heavy smoker(reaching or more than 20 cigarettes a day).
- •Subject is pregnant or lactating or within 1 year after delivery.
- •Subject has a severe systemic disease, such as cardiovascular system
- •Subject has a history of malignancy or radiotherapy.
- •Subject has an allergic history to the drugs used in the study.
- •Subject has mental disorder incapable of elementary cooperations.
- •Subject has participated in other clinical researches of medicine within 3 month prior to randomization.
研究组 & 干预措施
Dingkundan
Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
干预措施: Dingkundan (Drug)
Dingkundan & Diane-35
Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
干预措施: Dingkundan & Diane-35 (Drug)
Diane-35
Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
干预措施: Diane-35 (Drug)
结局指标
主要结局
symptoms
时间窗: 5 minutes
PCOS symptoms
sex hormone levels changes
时间窗: 5 minutes
sex hormone levels changes
次要结局
- lipid metabolism(5 minutes)
- metabolites figure spectrum(5 minutes)
- Fasting insulin(5 minutes)
- glycosylated hemoglobin(5 minutes)
- fasting blood glucose(5 minutes)
研究者
Aijun Sun
Principal Investigator
Peking Union Medical College Hospital