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

NCT04425083 | Completed

• 1 other identifier: TSGH-C105-025
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Chinese Medical Constitution & Syndromes

Outcome Measures

Primary Outcomes (1)

• participants with PCOS and non-PCOS assessed Chinese Body Constitution & Syndromes by Body Constitution Questionnaire

  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.

  No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)

Secondary Outcomes (10)

• 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)

• 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)

Study Arms (2)

Polycystic Ovary Syndrome

Polycystic Ovary Syndrome women

Other: no intervention

control

non- Polycystic Ovary Syndrome women

Other: no intervention

Interventions

no intervention OTHER

no intervention

Polycystic Ovary Syndrome; control

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with Polycystic Ovary Syndrome and non Polycystic Ovary Syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of Chinese medicine

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 11, 2020
• Study Start: November 18, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: June 11, 2020

Record last verified: 2020-06