Clinical trial NCT02678546: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Rheumatologic Disease
Kidney Disease
Endocrine, Metabolic or Nutritional Diseases or Conditions
Keywords: Traditional Chinese Medicine
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, Taiwan
First posted: 2016-02-09
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: Inclusion Criteria:

* people above 20 years old

Exclusion Criteria:

* people who cannot understand the description of questionnaire

Primary outcomes:
measure: the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: 1 month
measure: the measure patterns of the Body Constitutions Questionnaire (BCQ)
timeFrame: 1 month
Secondary outcomes:
measure: the association between measure patterns of CCMQ and demographic life style factors
timeFrame: 1 month
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Hen-Hong Chang, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: