- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678546
Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim: Several questionnaires have been developed for clinical research in Traditional Chinese Medicine. The objective of this study is to evaluate the consistency and relevance of two questionnaires, the Constitution in Chinese Medicine Questionnaire (CCMQ) and the Body Constitutions Questionnaire (BCQ).
Method: Between December 2015 and December 2016, a sample of 150 participants aged above 20 years from the Chinese Medical University "elder college" curriculum and outpatients at the Hospital in Taichung, Taiwan, will be interviewed to complete both questionnaires based on subjective symptoms in a 3-d interval. There are three common patterns of body constitutions in CCMQ and BCQ: gentleness/plain, Ying-deficiency, and Yang-deficiency. As for other body constitutions, Qi-deficiency, phlegm-dampness, dampness-heat, blood-stasis, Qi-depression, and special diathesis are described only in CCMQ, while stasis is a feature only defined in BCQ. Average and standard deviation will be used to describe the measurement scores of the questionnaires and the percentages of constitution distribution. Statistical analysis of the Kappa value, Pearson Chi-Square, odds ratio, and Pearson's correlation coefficient would be employed to examine the consistency and association between the two questionnaires.
Expected result: The investigators hope to 1) describe the constitution profile of the study population; 2) assess the consistency between two questionnaires; and 3) examine the associations between CCMQ and demographic life style factors.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
-
Taichung, Taiwan, 404
- Recruiting
- China Medical University Hospital
-
Contact:
- Hen-Hong Chang, M.D., Ph.D.
- Phone Number: 3501 +886-4-22053366
- Email: tcmchh55@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- people above 20 years old
Exclusion Criteria:
- people who cannot understand the description of questionnaire
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients in outpatients departments
patients from outpatients departments in teaching hospital
|
case review of diagnosed disease
|
|
General
participants from center of continuing education in China Medical University
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ)
Time Frame: 1 month
|
1 month
|
|
the measure patterns of the Body Constitutions Questionnaire (BCQ)
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the association between measure patterns of CCMQ and demographic life style factors
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hen-Hong Chang, M.D.,Ph.D., China Medical University, China
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH104-REC3-097
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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