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Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)

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ClinicalTrials.gov Identifier: NCT01920997
Recruitment Status : Unknown
Verified September 2013 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : August 13, 2013
Last Update Posted : September 4, 2013
Sponsor:
Collaborator:
Wuxi People's Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Tracking Information
First Submitted Date August 8, 2013
First Posted Date August 13, 2013
Last Update Posted Date September 4, 2013
Study Start Date August 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2013)
The expression of NEI network and Urine metabolomics [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01920997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Qing'E Formula Therapy on Menopausal Symptoms (Healthy Volunteers Recruitment for Control Study)
Official Title Not Provided
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 Provided
Study Type Observational
Study Design Observational Model: Case Control
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy women with normal menstrual cycles aged 40-50
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts No drug intervention
The objective of this study is to investigate the expression of NEI network and urine metabolomics of healthy women with normal menstrual cycles.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 12, 2013)
50
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Healthy women with normal menstrual cycles aged 40-50.
  2. The score of Kupperman index is less than 15.
  3. Not alcoholics or smokers (past or smoking).
  4. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

  1. Volunteers with heart, liver, kidney disease or acute or chronic gastrointestinal diseases, or with diseases of blood, endocrine, neurological and other systems.
  2. Volunteers are participating in other clinical trials within 3 months.
  3. Volunteers who donated blood or loosed blood heavily within 3 months.
  4. Volunteers with previous history of mental illness, drug abuse or drug dependence.
  5. Volunteers who took drugs within 14 days before the trail.
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01920997
Other Study ID Numbers QE-2458-3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shanghai University of Traditional Chinese Medicine
Study Sponsor Shanghai University of Traditional Chinese Medicine
Collaborators Wuxi People's Hospital
Investigators Not Provided
PRS Account Shanghai University of Traditional Chinese Medicine
Verification Date September 2013