Polycystic Ovary SyndromeNCT04425083
Relationship of the Chinese Medical Constitution & Syndromes in Patients With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Tri-Service General Hospital (TSGH).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women diagnosed with Polycystic Ovary Syndrome and non Polycystic Ovary Syndrome
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Study of the Relationship of the Chinese Medical Constitution & Syndromes and Quality of Life in Patients With Polycystic Ovary Syndrome
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- no intervention
- Keywords
- Polycystic Ovary Syndrome, Chinese Medical Constitution & Syndromes
- Medical subject headings
- Polycystic Ovary Syndrome, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Polycystic Ovary Syndrome | Polycystic Ovary Syndrome women Receives: Other: no intervention | |
| control | non- Polycystic Ovary Syndrome women Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participant reply her work schedule (Day shift, Evening shift, Night shift, Not fixed, or Unemployed)
Measured: 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
Participant reply her average sleep duration (hours)
Measured: 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
Participant reply her frequency(No, Sometimes, Often) of staying up late (sleeping after midnight)
Measured: 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
Participant reply her frequency of smoking (No, Sometimes, Less than a pack a day)
Measured: 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
Participant reply her frequency of drinking (No, Sometimes, often)
Measured: 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
Participant reply her frequency of exercise (No, Sometimes, often)
Measured: 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
Participant reply her dietary habit (Nonvegetarian or vegetarian)
Measured: 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
Participant reply yes or no about her dietary flavor preference (sour, bitter,sweet, spicy, salty)
Measured: 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
The Beck Anxiety Inventory (BAI) was established by Aaron T. Beck and his research team to measure the anxiety levels of adults and teenagers. It is a self-completed questionnaire with 21 items. The questions ask respondents whether they have experienced some common symptoms of anxiety in the previous week, including numbness or tingling, feeling hot, being unable to relax, and fear of the worst happening. The respondents report on a 4-point Likert scale that ranges from 0 (Not at all) to 3 (Severely - it bothered me a lot). The higher the total score is, the more severe the anxiety symptoms are. A total score of 0-7 implies the mildest anxiety, 8-15 is mild anxiety, 16-25 represents moderate anxiety, and 26-63 is severe anxiety. In the present study, the Chinese version of the BAI had a Cronbach's α of 0.95 and a split-half reliability of 0.92. The total scores were multiplied by 1.19, and the resulted integers were taken as the standard scores.
Measured: 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)
The Beck Depression Inventory-second edition (BDI-II) was developed by Beck . It measures the depression levels of teenagers and adults through 21 questions. It consists of questions representative of the symptoms and attitudes of depression, such as feeling sad, losing interest, decreased appetite, and feeling tired. For each item, respondents select the option that best describes how they felt over the previous 2 weeks. Every question has anchors arranged according to severity, and the score ranges from 0 to 3 points. The higher the total score is, the more severe the depression symptoms are. A total score of 0-13 points is in the normal range, 14-19 implies mild depression, 20-28 moderate depression, and 29-63 severe depression.
Measured: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start18 Nov 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Jung Lin, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425083
- Sponsor's protocol ID
- TSGH-C105-025
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship of the Chinese Medical Constitution & Syndromes and Quality of Life in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04425083
- Acronym / sponsor ID
- TSGH-C105-025
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Chinese Medical Constitution & Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycystic Ovary Syndrome | – | Other: no interventionPolycystic Ovary Syndrome women |
| control | – | Other: no interventionnon- Polycystic Ovary Syndrome women |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with Polycystic Ovary Syndrome and non Polycystic Ovary Syndrome
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Polycystic Ovary Syndrome, control |
Primary outcome
participants with PCOS and non-PCOS assessed Chinese Body Constitution & Syndromes by Body Constitution Questionnaire
Time frame: 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.
10 secondary outcomes
work schedule (Day shift, Evening shift, Night shift, Not fixed, or Unemployed) of participants with PCOS and non-PCOS were collected
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
participants with PCOS and non-PCOS assessed Chinese Body Constitution & Syndromes by Body Constitution Questionnaire (time frame: No subsequent intervention, data collected and analyzed at the time of enrolled (cross-sectional study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.