The Safety and Efficacy of L-arginine in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- menstrual frequency
研究概览
简要总结
PCOS patients meeting the trial criteria were enrolled from the Shanghai 10th People's Hospital. The contents of this study were introduced to them, and they were invited to participate in the study. We further evaluated the efficacy and safety of arginine in treating PCOS by implementing the L-arginine clinical intervention protocol, and conducting post-intervention follow-up, efficacy evaluation, laboratory tests, and fecal sample 16S rRNA sequencing.
详细描述
In this study, we will enroll PCOS patients who meet the trial criteria from the Shanghai 10th People's Hospital, introduce the content of this study to them, and invite them to participate in the study. Perform laboratory tests for PCOS and collect baseline stool and blood samples. The clinical intervention program of L-arginine was implemented, and post-intervention follow-up, efficacy evaluation and laboratory examination were carried out. Stool and blood samples were collected after the intervention, and 16S rRNA sequencing was performed on stool samples before and after the intervention. To analyze whether PCOS-related clinical and laboratory indicators improved after L-arginine treatment of PCOS, and to analyze the changes in patients' microbiome before and after L-arginine treatment, to clarify the effectiveness and safety of L-arginine treatment of PCOS.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 18-45 years
- •Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
排除标准
- •Pregnant women;
- •Hyperthyroidism or hypothyroidism
- •Severe liver and kidney function injury
- •Cancer patients;
- •Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
- •Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
- •Patients with mental illness or intellectual disability;
- •Have a long history of taking hormone therapy;
- •Currently or recently participating in another clinical trial.
研究组 & 干预措施
L-arginine intervention with 3g daily treatment for three months
L-arginine therapy
干预措施: L-arginine intervention (Drug)
结局指标
主要结局
menstrual frequency
时间窗: Within 7 days of enrollment
number of menstruation in a year
次要结局
- Homeostasis model assessment of insulin resistance(Within 7 days of enrollment)
- body mass index(Within 7 days of enrollment.)
- fasting glucose(Within 7 days of enrollment.)
- fasting insulin(Within 7 days of enrollment.)
- Total cholesterol(Within 7 days of enrollment.)
- Triglycerides(Within 7 days of enrollment.)
- HDL-c(Within 7 days of enrollment.)
- LDL-c(Within 7 days of enrollment.)
- total testosterone(Within 7 days of enrollment.)
- free testosterone(Within 7 days of enrollment.)
- Sex hormone-binding globulin(Within 7 days of enrollment.)
- Androstenedione(Within 7 days of enrollment.)
- Dehydroepiandrosterone(Within 7 days of enrollment.)
研究者
Zhang Manna
Prof.
Shanghai 10th People's Hospital