CompletedInterventionalPhase 3Updated Jun 18, 2012
Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study) | NCT01920997 | Trialant
Unknown statusObservationalUpdated Sep 4, 2013
Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)
ClinicalTrials.gov ID
NCT01920997
Lead Sponsor
Shanghai University of Traditional Chinese MedicineOTHER
Overall Status
Unknown status
Study Type
Observational
Enrollment
50Estimated
Last Update Posted
Sep 4, 2013Estimated
Start Date
Aug 2013
Primary Completion Date
Oct 2013Estimated
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.
Healthy
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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.
Observational Model
Case-Control
Zheng Qingshan, PhDContact
zheng.zqs@gmail.com+86-021-51322556
Shanghai University of Traditional Chinese MedicineRecruiting
Shanghai, Shanghai Municipality 210038, China
Yang Jie, MDContact
yangjie@wuxiph.com+86-0510-85350351
He Qing, MDPrincipal Investigator
Lead Sponsor
Shanghai University of Traditional Chinese MedicineOTHER