Clinical trial NCT04425083: Relationship of the Chinese Medical Constitution & Syndromes in Patients With Polycystic Ovary Syndrome
Official title: Study of the Relationship of the Chinese Medical Constitution & Syndromes and Quality of Life in Patients With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Chinese Medical Constitution & Syndromes
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with Polycystic Ovary Syndrome and non Polycystic Ovary Syndrome

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: participants with PCOS and non-PCOS assessed Chinese Body Constitution & Syndromes by Body Constitution Questionnaire
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
Secondary outcomes:
measure: work schedule (Day shift, Evening shift, Night shift, Not fixed, or Unemployed) of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: average sleep duration of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: habit of staying up late of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: habit of smoking of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: habit of drinking of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: habit of exercise of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: dietary habit (Nonvegetarian or vegetarian) of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: dietary flavor preference (sour, bitter,sweet, spicy, salty) of participants with PCOS and non-PCOS were collected
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: Anxiety of participants with PCOS and non-PCOS as assessed by Beck Anxiety Inventory
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
measure: Depression of participants with PCOS and non-PCOS as assessed by Beck Depression Inventory-second edition (BDI-II)
timeFrame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
Other outcomes:
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