Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)
- Conditions
- Healthy
- Registration Number
- NCT01920997
- Lead Sponsor
- Shanghai University of Traditional Chinese Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
- Healthy women with normal menstrual cycles aged 40-50.
- The score of Kupperman index is less than 15.
- Not alcoholics or smokers (past or smoking).
- Get subjects informed consent process should comply with GCP requirements.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The expression of NEI network and Urine metabolomics 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China