Autoimmune Rheumatologic DiseaseNCT02678546
Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population
An observational study of Autoimmune Rheumatologic Disease and Kidney Disease, run by China Medical University Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Rheumatologic Disease, Kidney Disease, Endocrine, Metabolic or Nutritional Diseases or Conditions
- What is being tested?
- Other
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2016
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General Population from Center of Continuing Education in China Medical University and patients from China Medical University Hospital
Who may be able to join
- people above 20 years old
Who cannot join
- people who cannot understand the description of questionnaire
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Hen-Hong Chang, M.D., Ph.D., +886-4-22053366 ext. 3501, tcmchh55@gmail.com
About this study
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).
Read the 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
- Autoimmune Rheumatologic Disease, Kidney Disease, Endocrine, Metabolic or Nutritional Diseases or Conditions
- Being tested
- Other
- Keywords
- Traditional Chinese Medicine
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
case review of diagnosed disease
| Study group | Role | What they receive |
|---|---|---|
| patients in outpatients departments | patients from outpatients departments in teaching hospital Receives: Other: Other | |
| General | participants from center of continuing education in China Medical University |
What is being measured
The primary outcome is the main question the study is designed to answer.
the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ)
Measured: 1 month
the measure patterns of the Body Constitutions Questionnaire (BCQ)
Measured: 1 month
Secondary outcomes (1)
the association between measure patterns of CCMQ and demographic life style factors
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Rheumatologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hen-Hong Chang, M.D.,Ph.D., Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678546
- Sponsor's protocol ID
- CMUH104-REC3-097
- Status last verified
- Aug 2016
- First submitted
- 12 Jan 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population
- ClinicalTrials.gov ID
- NCT02678546
- Acronym / sponsor ID
- CMUH104-REC3-097
- Conditions
- Autoimmune Rheumatologic Disease, Kidney Disease, Endocrine, Metabolic or Nutritional Diseases or Conditions
- Keywords
- Traditional Chinese Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, Taiwan
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients in outpatients departments | – | Other: Otherpatients from outpatients departments in teaching hospital |
| General | – | –participants from center of continuing education in China Medical University |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General Population from Center of Continuing Education in China Medical University and patients from China Medical University Hospital
Key inclusion criteria (1 listed)
- people above 20 years old
Key exclusion criteria (1 listed)
- people who cannot understand the description of questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Othercase review of diagnosed disease | Other | patients in outpatients departments |
Primary outcome
the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: 1 month
the measure patterns of the Body Constitutions Questionnaire (BCQ)
Time frame: 1 month
1 secondary outcome
the association between measure patterns of CCMQ and demographic life style factors
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hen-Hong Chang, M.D.,Ph.D. principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Rheumatologic Disease and Kidney Disease, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hen-Hong Chang, M.D.,Ph.D. (+886-4-22053366 ext. 3501, tcmchh55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the measure patterns of the Constitution in Chinese Medicine Questionnaire (CCMQ) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.