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

NCT ID: NCT01920997

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Healthy normal menstrual cycles

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wuxi People's Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zheng Qingshan, PhD

Role: CONTACT

Phone: +86-021-51322556

Email: [email protected]

Facility Contacts

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Yang Jie, MD

Role: primary

Other Identifiers

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QE-2458-3

Identifier Type: -

Identifier Source: org_study_id