Traditional Chinese Medicine Body ConstitutionNCT05943483
To Establish the Traditional Chinese Medicine Based Intelligent Personal Health Care System
An observational study of Traditional Chinese Medicine Body Constitution, run by Sheng-Teng Huang at 1 site in Taiwan.
Trial summary
Development of a New Generation Chinese Medicine Constitution Assessment Scale Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Traditional Chinese Medicine Body Constitution
- What is being tested?
- CCMQ questionnaire
- How many people
- 1,918 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Jul 2022
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The enrolled normal subjects were confirmed by the Association and the research Principal Investigator (PI). Subjects between the ages of 18 and 85 were included. We collected all of the subjects' basic information and administered the Chinese Medicine Constitution Assessment Scale.
Who may be able to join
- Aged over 18 and under 85.
- Participants agreed to join the trial by fully understanding the purpose of the study and the entire trial process and then signed an informed consent.
- Able to fill out online questionnaire with any electronic device in person or under assistance
Who cannot join
- Age of subjects was under 18 or more than 85 years old.
- Participants who do not meet the above criteria
- Subjects were not willing sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Development of a New Generation Chinese Medicine Constitution Assessment Scale
Read the detailed description
Development of a New Generation Chinese Medicine Constitution Assessment Scale:
- Analyzing the existing CCMQ and BCQ questionnaire syntax. B. Redesigning the scale's question statements. C. Reintegrating the scale items and constitutional characteristics. D. Testing and evaluating the reliability and validity of the questionnaire, cross-assessing with diagnoses from experienced Chinese medicine practitioners.
- Collecting feedback and reviewing modifications based on the responses from the general population questionnaire.
- Being tested
- CCMQ questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCMQ questionnaireOther
Test subjects were required to fill out our modified CCMQ (Constitution in Chinese Medicine Questionnaire) Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Subjects who filled out our modified CCMQ questionnaire Receives: Other: CCMQ questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constitution in Chinese Medicine Questionnaire(CCMQ)_modified version
Based on the analysis, we have identified nine different types of Traditional Chinese Medicine constitutions.
Measured: On the 1 day of receipt
Secondary outcomes (1)
Base Data Questionnaire
Included collection of basic data (age, BMI, gender, place of residence, education level, smoking status, alcohol drinking, betel nut chewing, exercise frequency, work shift jobs and bedtime), disease status.
Measured: On the 1 day of receipt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Aug 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Chinese Medicine Body ConstitutionStudies 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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,918 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheng-Teng Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng-Teng Huang, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943483
- Sponsor's protocol ID
- CMUH109-REC1-026
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are not planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Establish the Traditional Chinese Medicine Based Intelligent Personal Health Care System
- ClinicalTrials.gov ID
- NCT05943483
- Acronym / sponsor ID
- CMUH109-REC1-026
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,918 participants (actual)
- Lead sponsor
- Sheng-Teng HuangUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 13 Jul 2023 (actual)
- 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.
Development of a New Generation Chinese Medicine Constitution Assessment Scale
Detailed description
Development of a New Generation Chinese Medicine Constitution Assessment Scale:
- Analyzing the existing CCMQ and BCQ questionnaire syntax. B. Redesigning the scale's question statements. C. Reintegrating the scale items and constitutional characteristics. D. Testing and evaluating the reliability and validity of the questionnaire, cross-assessing with diagnoses from experienced Chinese medicine practitioners.
- Collecting feedback and reviewing modifications based on the responses from the general population questionnaire.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Other: CCMQ questionnaireSubjects who filled out our modified CCMQ questionnaire |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The enrolled normal subjects were confirmed by the Association and the research Principal Investigator (PI). Subjects between the ages of 18 and 85 were included. We collected all of the subjects' basic information and administered the Chinese Medicine Constitution Assessment Scale.
Key inclusion criteria (3 listed)
- Aged over 18 and under 85.
- Participants agreed to join the trial by fully understanding the purpose of the study and the entire trial process and then signed an informed consent.
- Able to fill out online questionnaire with any electronic device in person or under assistance
Key exclusion criteria (3 listed)
- Age of subjects was under 18 or more than 85 years old.
- Participants who do not meet the above criteria
- Subjects were not willing sign the informed consent.
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 |
|---|---|---|
| CCMQ questionnaireTest subjects were required to fill out our modified CCMQ (Constitution in Chinese Medicine Questionnaire) Questionnaire. | Other | All subjects |
Primary outcome
Constitution in Chinese Medicine Questionnaire(CCMQ)_modified version
Time frame: On the 1 day of receipt
Based on the analysis, we have identified nine different types of Traditional Chinese Medicine constitutions.
1 secondary outcome
Base Data Questionnaire
Time frame: On the 1 day of receipt
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No. IPD are not planned to be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Traditional Chinese Medicine Body Constitution, run by Sheng-Teng Huang 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constitution in Chinese Medicine Questionnaire(CCMQ)_modified version (time frame: On the 1 day of receipt). 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 13 Jul 2023.