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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by China Medical University Hospital
Sponsor:
Collaborator:
China Medical University, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT02678546
First received: January 12, 2016
Last updated: February 8, 2016
Last verified: February 2016
  Purpose
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).

Condition Intervention
Autoimmune Rheumatologic Disease
Kidney Disease
Endocrine, Metabolic or Nutritional Diseases or Conditions
Other: Other

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Days
Official Title: Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • the measure patterns of the Body Constitutions Questionnaire (BCQ) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the association between measure patterns of CCMQ and demographic life style factors [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients in outpatients departments
patients from outpatients departments in teaching hospital
Other: Other
case review of diagnosed disease
General
participants from center of continuing education in China Medical University

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • people above 20 years old

Exclusion Criteria:

  • people who cannot understand the description of questionnaire
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02678546

Contacts
Contact: Hen-Hong Chang, M.D.,Ph.D. +886-4-22053366 ext 3501 tcmchh55@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Hen-Hong Chang, M.D., Ph.D.    +886-4-22053366 ext 3501    tcmchh55@gmail.com   
Sponsors and Collaborators
China Medical University Hospital
China Medical University, Taiwan
Investigators
Principal Investigator: Hen-Hong Chang, M.D.,Ph.D. China Medical University, China
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02678546     History of Changes
Other Study ID Numbers: CMUH104-REC3-097 
Study First Received: January 12, 2016
Last Updated: February 8, 2016
Health Authority: Taiwan: Institutional Review Board

Keywords provided by China Medical University Hospital:
Traditional Chinese Medicine

Additional relevant MeSH terms:
Autoimmune Diseases
Chronic Disease
Kidney Diseases
Nutrition Disorders
Rheumatic Diseases
Connective Tissue Diseases
Disease Attributes
Immune System Diseases
Musculoskeletal Diseases
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on February 08, 2016