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Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population

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ClinicalTrials.gov Identifier: NCT02678546
Recruitment Status : Unknown
Verified August 2016 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : August 2, 2016
Sponsor:
Collaborator:
China Medical University, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital

Tracking Information
First Submitted Date January 12, 2016
First Posted Date February 9, 2016
Last Update Posted Date August 2, 2016
Study Start Date January 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2016)
  • the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ) [ Time Frame: 1 month ]
  • the measure patterns of the Body Constitutions Questionnaire (BCQ) [ Time Frame: 1 month ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02678546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 8, 2016)
the association between measure patterns of CCMQ and demographic life style factors [ Time Frame: 1 month ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population
Official Title Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population
Brief 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).
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 Observational [Patient Registry]
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration 3 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population General Population from Center of Continuing Education in China Medical University and patients from China Medical University Hospital
Condition
  • Autoimmune Rheumatologic Disease
  • Kidney Disease
  • Endocrine, Metabolic or Nutritional Diseases or Conditions
Intervention Other: Other
case review of diagnosed disease
Study Groups/Cohorts
  • patients in outpatients departments
    patients from outpatients departments in teaching hospital
    Intervention: Other: Other
  • General
    participants from center of continuing education in China Medical University
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 8, 2016)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • people above 20 years old

Exclusion Criteria:

  • people who cannot understand the description of questionnaire
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02678546
Other Study ID Numbers CMUH104-REC3-097
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party China Medical University Hospital
Study Sponsor China Medical University Hospital
Collaborators China Medical University, Taiwan
Investigators
Principal Investigator: Hen-Hong Chang, M.D.,Ph.D. China Medical University, China
PRS Account China Medical University Hospital
Verification Date August 2016