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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02678546
Other study ID # CMUH104-REC3-097
Secondary ID
Status Recruiting
Phase N/A
First received January 12, 2016
Last updated August 1, 2016
Start date January 2016
Est. completion date December 2016

Study information

Verified date August 2016
Source China Medical University Hospital
Contact Hen-Hong Chang, M.D.,Ph.D.
Phone +886-4-22053366
Email tcmchh55@gmail.com
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- people above 20 years old

Exclusion Criteria:

- people who cannot understand the description of questionnaire

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Other
case review of diagnosed disease

Locations

Country Name City State
Taiwan China Medical University Hospital Taichung

Sponsors (2)

Lead Sponsor Collaborator
China Medical University Hospital China Medical University, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ) 1 month No
Primary the measure patterns of the Body Constitutions Questionnaire (BCQ) 1 month No
Secondary the association between measure patterns of CCMQ and demographic life style factors 1 month No
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