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临床试验/NCT05465135
NCT05465135已完成4 期

The Evaluation of the Effect of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Recovery of regular menses by questionnaire

研究概览

简要总结

Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin also has some significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigators' previous studies discovered that Artemisinin dramatically reduced serum androgen levels and improved poly-cystic ovary syndrome(PCOS) in animals. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.

详细描述

Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by a combination of genetic and environmental factors. The pathogenesis of PCOS remains unclear. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin has significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigator's previous studies found that artemisinin and its derivatives could significantly promote uncoupling protein 1 (UCP1) transcription and the conversion of white fat to brown fat. Artemisinin derivatives upregulated the levels of genes critical for brown fat differentiation and function, accompanied by enhanced mitochondrial biosynthesis, demonstrating their potential to promote white fat browning and improve metabolism in rodent models. The investigators also observed that androgen levels in drug-induced PCOS rats were reduced, when treated with artemether analogs for prophylactic and therapeutic purposes, respectively. It is believed that the two core mechanisms in the pathogenesis of PCOS are excessive androgen synthesis and insulin resistance. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both serum androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms and control or even reverse the disease progression. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.

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
16 Years 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI 23-30kg/M2
  • No plan for pregnancy in the coming 6 months
  • Newly diagnosed PCOS, or PCOS without any medication for the past three months.
  • Patients should meet all the three following criteria:
  • Oligomenorrhea or amenorrhea: Oligomenorrhea is defined as more than 35 days between menstrual periods and less than 8 menstrual bleedings in the past year; amenorrhea is defined as more than 90 days between two menstrual bleedings.
  • Polycystic ovaries: ≥12 follicles in both ovaries (diameter<10mm), confirmed by ultrasound.
  • Elevated androgen levels: testosterone>1.67 nmol/L.

排除标准

  • Previously treated with steroids or other medications for PCOS in the past 3 months.
  • Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc.
  • Pregnancy.
  • 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 Group

Experimental

The subjects take Dihydroartemisinin, 40mg tid for 12 weeks

干预措施: Dihydroartemisinin (Drug)

结局指标

主要结局

Recovery of regular menses by questionnaire

时间窗: 12 weeks

Periodical vaginal bleeding by questionnaire

Bilateral ovary volume

时间窗: 12 weeks

Length, width and height of bilateral ovaries measured by B type ultrasound

Number of immature follicles

时间窗: 12 weeks

Total number of follicles with diameters \<10 mm measured by B type ultrasound

Serum testosterone levels

时间窗: 12 weeks

Measurement of serum total testosterone

次要结局

  • Sex hormone binding globulin (SHBG)(12 weeks)
  • Serum anti-Mullerian hormone(12 weeks)
  • Serum dehydroepiandrosterone sulfate(12 weeks after drug intervention)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaoying Li

Director

Shanghai Zhongshan Hospital

研究点 (1)

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