Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- basal testosterone
研究概览
简要总结
Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese medicine, this herb has been widely prescribed for several pathologies, including diabetes, acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of key molecules during both insulin signaling and androgen synthesis.The purpose of this study is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary Syndrome (PCOS) symptomatology.
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 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of PCOS diagnosed based on the Androgen Excess Society criteria. All subjects must have hyperandrogenism (hirsutism and/or hyperandrogenemia), ovarian dysfunction (oligoanovulation and/or polycystic ovaries), and exclusion of other androgen excess related disorders. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism is defined as a Ferriman-Gallwey (FG) score ≥5
- •Age of women from 18 to 35 years；
- •No desire of children within 6 month and use condoms for contraception.
排除标准
- •Use of hormonal drugs or other medications, which can affect the results of the study especially Chinese herbal prescriptions in the past 12 weeks；
- •Patients with other androgen excess endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, severe insulin resistance, thyroid dysfunction；
- •Patients with history of sever cardiac , pulmonary, hepatic, renal, neurologic disease or mental illness；
- •Pregnancy or lactation.
研究组 & 干预措施
tanshinone
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
干预措施: tanshinone (Drug)
tanshinone placebo
placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
干预措施: tanshinone placebo (Drug)
结局指标
主要结局
basal testosterone
时间窗: 3 months
The primary outcome measure is a decrease in basal testosterone.
次要结局
- Adverse events(3 months)
- Ovarian androgen biosynthesis(3 months)
- Whole body insulin action(3 months)
- Oral glucose tolerance test (OGTT)(3 months)
- Reproductive hormones(3 months)
- Fasting gluco-lipid metabolic profiles(3 months)
- quality of life(3 months)
- Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment(3 months)
研究者
Xiaoke Wu
Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital
Heilongjiang University of Chinese Medicine