The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total metabolites detection using LC/MS/MS
研究概览
简要总结
Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of complicated chemical constituents. Many confounding factors influence activity of Chinese herbs, including the origin of the herbs, safety of the products and consistency between batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more challengeable due to unresolved problems of product quality control, screen of effective principles, monitor of the marker constituents and the targets for site of action. In this project, we will introduce the concept of metabolomics to detect total metabolites spectra as the biomarkers of Chinese herbs intervention. Correlation will be analyzed between changes in total metabolites and clinical improvements when menopausal women receive Suan Tsao Jen Tang or Jia Wey Shiau Yau San, and postpartum women receive 生化湯.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Insomnia according to PSQI>6
- •Informed consent
- •Age 40-65 years
排除标准
- •In 3 months before participating in and studying, happen great accident or heavy night shift or have time difference problems (such as the long-range flight) .
- •Spiritual disease (melancholia,etc.) ,obstructive sleep apnea, heart disease history (the acute heart attack, cardiac arrhythmia) , hypertension , diabetes mellitus, cancer.
- •Take melatonin or melatonin agonist, such medicines as acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins,etc..
研究组 & 干预措施
Suan Tsao Jen Tang
干预措施: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San (Drug)
Jia-Wey Shiau-Yau San
干预措施: Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San (Drug)
结局指标
主要结局
Total metabolites detection using LC/MS/MS
时间窗: one month
次要结局
- 1.Menopause rating scale (MRS) 2.Pittsburgh sleep quality index (PSQI)(one month)