Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

Body Constitution Clinical Trial

Official title:

Epidemiological Study on Body Constitution Classified by Traditional Chinese Medicine Theory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335306
• Other study ID #: HKCTR-1355
• Status: Completed
• Phase: N/A
• First received: October 24, 2017
• Last updated: January 7, 2018
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Different people are classified into different physiological constitution types in the Traditional Chinese Medicine (TCM) theory. Two instruments, the Body Constitution Questionnaire (BCQ) and the Constitution in Chinese Medicine Questionnaire (CCMQ), have been developed in Taiwan and Mainland China respectively to measure constitution. They were adapted and pilot tested in primary care Chinese patients in Hong Kong, which showed acceptable validity and reliability. These instruments have potential applications for epidemiological studies on body constitution.

Aim and objectives: The aim of this study is to establish the prevalence and epidemiology of body constitution classified by the Traditional Chinese Medicine Theory in the Chinese population in Hong Kong. It would also determine whether the prevalence of constitution types change with seasons and whether it is associated with socio-demographic factors, place of origin or residence, life style, or quality of life.

Design and subjects: Two cross-sectional telephone surveys of the Hong Kong (HK) general Chinese population, one in Summer and one in Winter, will be carried out. Sample size for each survey is 3200 subjects.

Methods: Residential-telephone-owning households will be contacted through random dialing by the Social Science and Research Centre of the University of Hong Kong using the Computer-Assisted Telephone Interviewing (CATI) system that covers 95% households in Hong Kong. A member, aged 18 or above, of the contacted household who last had his/her birthday will be invited to the study to answer either the BCQ or the CCMQ and a structured questionnaire on socio-demographics, place of origin, place of residence, health service utilization, life style and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6400
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Can be contacted by in a residential telephone number

• Age 18 or above

• Chinese who can communicate in Cantonese or Chinese by telephone;

• Has given verbal consent to take part in the study

Exclusion Criteria:

• Cannot communicate in Cantonese or Chinese

• Persons who cannot communicate by telephone;

• Refuse to give consent

Related Conditions & MeSH terms

• Body Constitution

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong	Hksar

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Hospital Authority, Hong Kong, The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of constitution types classified by the BCQ or CCMQ	Proportion of different constitution types according to the BCQ or CCMQ questionnaire	Baseline only
Secondary	Short Form-12 (SF-12) Health-related quality of life of people with different constitution types		Baseline only
Secondary	Chinese quality of life (ChQOL) (HK version) Health-related quality of life of people with different constitution types		Baseline only