Traditional Chinese Medicine Constitution Study and the D... | NCT02678546

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jan 12, 2016

First Submission Date that Met QC Criteria

Feb 8, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2016

Last Update Posted Date

Aug 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

China Medical University HospitalOTHER

Collaborators

Name	Class
China Medical University, Taiwan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Autoimmune Rheumatologic Disease
Kidney Disease
Endocrine, Metabolic or Nutritional Diseases or Conditions

Keywords

Traditional Chinese Medicine

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients in outpatients departments		patients from outpatients departments in teaching hospital	Other: Other
General		participants from center of continuing education in China Medical University

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Other	Other	case review of diagnosed disease	patients in outpatients departments

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ)		1 month
the measure patterns of the Body Constitutions Questionnaire (BCQ)		1 month

Secondary Outcomes

Measure	Description	Time Frame
the association between measure patterns of CCMQ and demographic life style factors		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

people above 20 years old

Exclusion Criteria:

people who cannot understand the description of questionnaire

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

General Population from Center of Continuing Education in China Medical University and patients from China Medical University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hen-Hong Chang, M.D.,Ph.D.	Contact	+886-4-22053366	3501	tcmchh55@gmail.com

Overall Officials

Name	Affiliation	Role
Hen-Hong Chang, M.D.,Ph.D.	China Medical University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital	Recruiting	Taichung		404	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases