Study of the Relationship of the Chinese Medical Constitution & Syndromes and Quality of Life in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- participants with PCOS and non-PCOS assessed Chinese Body Constitution & Syndromes by Body Constitution Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Exclude diseases similar to the clinical manifestations of polycystic ovary, such as cushing syndrome, congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia.
- •Diagnose a clear mental disorder (such as schizophrenia, severe depression) or take psychiatric drugs (anti-depression or anxiety drugs).
- •Pregnancy, oral contraceptives, use high-dose exogenous androgens, breastfeeding.
- •Those with a history of stroke, myocardial infarction, major trauma or surgery within the past six months.
- •Have taken Chinese medicine in the past month.
结局指标
主要结局
participants with PCOS and non-PCOS assessed Chinese Body Constitution & Syndromes by Body Constitution Questionnaire
时间窗: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
The TCM Body Constitution Questionnaire (BCQ) was developed by Su and is a tool used to measure and study constitution deviations clinically. The questionnaire comprises 44 questions and employs a Likert 5-point scale (from 1, "Never happens," to 5, "Always happens"). The instrument consists of three subscales. The yang-xu and yin-xu constitution subscales each have 19 questions, and the stasis constitution subscale has 16 questions. The three measures share some questions. The higher the score is, the more significant the constitution deviation is. When the yang-xu constitution score is ≥ 30.5, the respondent is diagnosed as yang-xu. When the yin-xu constitution score is ≥ 29.5, the respondent is diagnosed as yin-xu. For the phlegm stasis constitution, the standard is ≥ 26.5 points. The instrument has favorable factorial validity. Cronbach's α of each subscale is 0.85-0.88, and Cronbach's αof the overall BCQ reaches 0.90.
次要结局
- work schedule (Day shift, Evening shift, Night shift, Not fixed, or Unemployed) of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- average sleep duration of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- habit of staying up late of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- habit of smoking of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- dietary habit (Nonvegetarian or vegetarian) of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- dietary flavor preference (sour, bitter,sweet, spicy, salty) of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- Anxiety of participants with PCOS and non-PCOS as assessed by Beck Anxiety Inventory(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- habit of drinking of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- habit of exercise of participants with PCOS and non-PCOS were collected(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
- Depression of participants with PCOS and non-PCOS as assessed by Beck Depression Inventory-second edition (BDI-II)(No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study))
研究者
Chien-Jung Lin
department of Chinese medicine
Tri-Service General Hospital