Therapeutic Efficacy of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recovery of regular menses
研究概览
简要总结
The primary research hypothesis of this study is that dihydroartemisinin is effective in restoration of regular menstrual cycles of PCOS subjects who meet at least two of three Rotterdam Criteria. Secondary research hypotheses include: dihydroartemisinin is also effective in reducing androgen, total immature follicles, and anti-Mullerian hormone.
详细描述
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by genetic and environmental factors. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, artemisinin has also been reported to have significant anti-inflammatory, anti-tumor and immune-modulating effects. Our recent study revealed that artemisinin derivatives protect against PCOS development by inhibiting ovarian androgen production. Consistently in a small pilot study, dihydroartemisinin effectively reduced androgen levels, reduced immature follicles, and improved the estrous cycle in PCOS patients who strictly met all the three Rotterdam Criteria, namely hyperandrogenism, ovulation dysfunction, and polycystic ovaries on ultrasound. Nevertheless, clinical diagnosis of PCOS can be established as long as a patient fulfill two of the three Rotterdam Criteria. The present study aims to explore the therapeutic effects of dihydroartemisinin in patients with PCOS who met at least two of three (≥2) Rotterdam Criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •BMI 18.5-28kg/M2
- •No plan for pregnancy in the coming 6 months
- •Patients should meet two of the three following criteria:
- •Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle
- •Polycystic ovaries: ≥12 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound.
- •Elevated androgen levels: total testosterone>1.67 nmol/L.
排除标准
- •Pregnancy.
- •Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc.
- •Patients with other serious diseases affecting heart, liver, kidney, or other major organs.
- •Patients with any type of cancer.
研究组 & 干预措施
Dihydroartemisinin Treatment Arm
The subjects take dihydroartemisinin, 40mg tid for 90 days
干预措施: Dihydroartemisinin (Drug)
结局指标
主要结局
Recovery of regular menses
时间窗: 180 days
Record of vaginal bleeding within 6 months after start taking dihydroartemisinin
次要结局
- Free androgen index (FAI)(90 days)
- Number of immature follicles(90 days)
- Serum anti-Mullerian hormone (AMH)(90 days)