NCT01920997Unknown不适用
Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)
Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The expression of NEI network and Urine metabolomics
研究概览
简要总结
This study will recruit 50 healthy women with normal menstrual cycles aged 40-50, to investigate the expression of their NEI network and urine metabolomics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women with normal menstrual cycles aged 40-
- •The score of Kupperman index is less than
- •Not alcoholics or smokers (past or smoking).
- •Get subjects informed consent process should comply with GCP requirements.
排除标准
- •Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems.
- •Volunteers are participating in other clinical trials within 3 months.
- •Volunteers who donated blood or loosed blood heavily within 3 months.
- •Volunteers with previous history of mental illness, drug abuse or drug dependence.
- •Volunteers who took drugs within 14 days before the trail.
结局指标
主要结局
The expression of NEI network and Urine metabolomics
时间窗: 2-5 days after menstruation
The indices of NEI network include: 1. Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT 2. Hypothalamic-pituitary-thyroid axis: TRH, T3, T4 3. Renin - angiotensin - aldosterone system: PRA, Ang2, ALD 4. Sex hormones: E2, FSH 5. Immune factors: TNF-α、IL-6、IL-1 6. Cardiovascular indicators: ET, NO, Hcy, Folic acid
次要结局
未报告次要终点
研究者
研究点 (1)
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