Relationship of the Chinese Medical Constitution & Syndromes in Patients With Polycystic Ovary Syndrome

NCT ID: NCT04425083

Last Updated: 2020-06-11

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

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-18

Study Completion Date

2017-12-31

Brief Summary

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This study is a cross-sectional study. The purpose is to understand the characteristics of Chinese medicine constitutional syndrome in patients with polycystic ovary. In addition, the health-related quality of life (SF-36), mental state (stress, depression) of patients with polycystic ovary , Anxiety) and the relationship between hormone biochemical indicators and TCM constitutional syndromes, to develop a pioneering study on TCM constitution diagnosis and life guidelines for polycystic ovarian patients and future clinical adjuvant therapy.

Detailed Description

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The study conducted in the Obstetrics and Gynecology Department of the Neihu District of the Taipei Three Military General Hospital. It is expected that 200 cases of polycystic ovary will be diagnosed by specialists; "Quality of Life Questionnaire (SF-36)" evaluates the quality of life of patients; "BAI and BDI-II" evaluates patients 'anxiety and depression; "Stress Perception Scale" evaluates patients' life stress And testing the blood indexes of patients such as FSH, LH, E2, testosterone, TSH, prolactine. Observe the correlation between the quality of life, psychological state, and blood test values of polycystic ovarian patients with physical characteristics of traditional Chinese medicine.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Polycystic Ovary Syndrome

Polycystic Ovary Syndrome women

no intervention

Intervention Type OTHER

no intervention

control

non- Polycystic Ovary Syndrome women

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

A polycystic ovarian patient was diagnosed by a specialist in obstetrics and gynecology according to the diagnostic criteria set by the Rotterdam ESHRE / ASRM-sponsored PCOS workshop group (2004) in 2003.

Exclusion Criteria

1. Exclude diseases similar to the clinical manifestations of polycystic ovary, such as cushing syndrome, congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia.
2. Diagnose a clear mental disorder (such as schizophrenia, severe depression) or take psychiatric drugs (anti-depression or anxiety drugs).
3. Pregnancy, oral contraceptives, use high-dose exogenous androgens, breastfeeding.
4. Those with a history of stroke, myocardial infarction, major trauma or surgery within the past six months.
5. Have taken Chinese medicine in the past month.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chien-Jung Lin

department of Chinese medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TSGH-C105-025

Identifier Type: -

Identifier Source: org_study_id

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