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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

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).

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

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
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
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ) [ Time Frame: 1 month ]
  2. the measure patterns of the Body Constitutions Questionnaire (BCQ) [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. the association between measure patterns of CCMQ and demographic life style factors [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678546


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

Locations
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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
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Principal Investigator: Hen-Hong Chang, M.D.,Ph.D. China Medical University, China

Additional Information:

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02678546     History of Changes
Other Study ID Numbers: CMUH104-REC3-097
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by China Medical University Hospital:
Traditional Chinese Medicine

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