Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease
Healthy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Study Start Date : August 2013
Estimated Primary Completion Date : October 2013

Group/Cohort
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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women with normal menstrual cycles aged 40-50
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920997


Contacts
Layout table for location contacts
Contact: Zheng Qingshan, PhD +86-021-51322556 zheng.zqs@gmail.com

Locations
Layout table for location information
China, Shanghai
Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 210038
Contact: Yang Jie, MD    +86-0510-85350351    yangjie@wuxiph.com   
Principal Investigator: He Qing, MD         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Wuxi People's Hospital

Layout table for additonal information
Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01920997     History of Changes
Other Study ID Numbers: QE-2458-3
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013
Keywords provided by Shanghai University of Traditional Chinese Medicine:
Healthy
normal menstrual cycles