Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- inflammatory marker IL1β [pg/ml]
研究概览
简要总结
The aim of this study is to elucidate the effects of red yeast rice on the improvement of symptoms in patients with polycystic ovary syndrome（PCOS）, and to analyze the dose-response relationship between intestinal microbiota and its metabolite, hydroxyindole, and clinical indicators of PCOS.
The main questions it aims to answer are:
How effective is red yeast rice in treating PCOS? Does the indole metabolic pathway of gut microbiota play a crucial role in the improvement of PCOS symptoms by red yeast rice? Participants will take 6 grams of red yeast rice daily for 6 months, and records will be kept of their PCOS clinical symptoms and indicators before the intervention, at the 3rd month post-intervention, and at the 6th month post-intervention. Additionally, biological samples from feces and serum will be collected at these time points.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Accept the red yeast rice intervention group
Red yeast rice (RYR), a fermented product that has both medicinal and edible properties, is one of the traditional Chinese medicines used in the treatment of metabolic diseases. The main components of red yeast rice include monacolins, monacolin K, red yeast rice pigments, ergosterol, stigmasterol, β-sitosterol, daucosterol.
干预措施: red yeast rice，RYR (Drug)
结局指标
主要结局
inflammatory marker IL1β [pg/ml]
时间窗: Baseline, the 3rd month and the 6th month after the intervention
testosterone (nmol/l)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
Follicle - Stimulating Hormone (mIU/mL)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
inflammatory marker IL18 [pg/ml]
时间窗: Baseline, the 3rd month and the 6th month after the intervention
Luteinizing Hormone (mIU/mL)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
Estradiol (pmol/l)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
Progesterone (ng/mL)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
Prolactin (ng/mL)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
follicles number
时间窗: Baseline, the 3rd month and the 6th month after the intervention
The number of follicles in each ovary of each participant will be determined by ultrasonography.
ovarian volume(Length x Width x Thickness/2,ml)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
The size of each ovary in each participant will be determined by ultrasonography.
Follicle diameter(mm)
时间窗: Baseline, the 3rd month and the 6th month after the intervention
The diameter of the follicles will be determined by ultrasonography.
Hydroxyindole concentration
时间窗: Baseline, the 3rd month and the 6th month after the intervention
次要结局
- Body-mass-index (BMI)(Baseline, the 3rd month and the 6th month after the intervention)
- waist-to-hip ratio(Baseline, the 3rd month and the 6th month after the intervention)
研究者
Zhengwei Wan
professor
Sichuan Provincial People's Hospital