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

Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02678546
• Other study ID #: CMUH104-REC3-097
• 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

• Autoimmune Diseases
• Autoimmune Rheumatologic Disease
• Chronic Disease
• Endocrine, Metabolic or Nutritional Diseases or Conditions
• Kidney Disease
• Kidney Diseases
• Nutrition Disorders
• Rheumatic Diseases

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