Non-disease StateNCT03653182
The Relation Between Constitutional Types and Indices of Tongue, Pulse,and Ausculative Diagnosis
An observational study of Non-disease State, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate indices of tongue diagnosis, ausculative diagnosis, and pulse diagnosis in the determination of institutions. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-disease State
- What is being tested?
- Pulse, tongue image, and voice sound
- How many people
- 281 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2010to 14 Dec 2011
- 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: aged older than 20 years old
Who may be able to join
- Volunteers without aged older than 20 years old
Who cannot join
- Pregnant
- taking any medicine currently
- suffering for acute disease currently
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate indices of tongue diagnosis, ausculative diagnosis, and pulse diagnosis in the determination of institutions.
Read the detailed description
Constitution differentiation is important for the prescription of Chinese medicines. In previous studies, researchers usually used constitutional questionnaires to determine constitutions.However, the importance of tongue diagnosis and pulse diagnosis remained unclear. The specific aim of this study is to evaluation indices of tongue diagnosis, auscultative diagnosis, and pulse diagnosis in the determination of constitutions. Meeting of specialists will determine the characteristics for each constitution first. This study plans to recruit 200 volunteers and determine their constitutions by constitutional questionnaires. Tongue manifestations and pulse pressure waveforms will be taken at the same time by standardized instruments. Relations between the indices and each constitution will be determined by multiple linear regression and logistic regression analysis. Then the percentage of importance of a specific index in a specific constitutional type could be determine.
- Conditions
- Non-disease State
- Being tested
- Pulse, tongue image, and voice sound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse, tongue image, and voice soundDiagnostic test
They are four diagnosis methods of TCM
| Study group | Role | What they receive |
|---|---|---|
| normal | A normal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Qi deficiency | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Damp heat | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Yang deficiency | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Yin deficiency | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Phlagm | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Blood stasis | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Qi stagnation | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound | |
| Special | One of an abnormal constitution condition in TCM. Receives: Diagnostic Test: Pulse, tongue image, and voice sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue image
A photograph of tongue will be taken and the RGB color values of the tongue will be analyzed using Photoshop software
Measured: The photograph will be taken only at the first day the subject has been recruited
Secondary outcomes (2)
Acoustic sound
Voice wave analysis of an one-second /a/ sound (in only one time point)
Measured: The voice waves will be taken only once at the first day the subject has been recruited
Pulse image
Time-domained pulse waveform of the radial artery will be recorded for about 1 minute
Measured: The pulse waveforms will be recorded at the first day the subject has been recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start15 Dec 2010
- Primary completion14 Dec 2011
- Study completion14 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-disease StateStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Committee on Chinese Medicine and Pharmacy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653182
- Sponsor's protocol ID
- DMR99-IRB-271
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Constitutional Types and Indices of Tongue, Pulse,and Ausculative Diagnosis
- ClinicalTrials.gov ID
- NCT03653182
- Acronym / sponsor ID
- DMR99-IRB-271
- Conditions
- Non-disease State
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Committee on Chinese Medicine and Pharmacy
- Study start
- 15 Dec 2010 (actual)
- Primary completion
- 14 Dec 2011 (actual)
- Study completion
- 14 Dec 2011 (actual)
- First posted
- 31 Aug 2018 (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.
This study aims to evaluate indices of tongue diagnosis, ausculative diagnosis, and pulse diagnosis in the determination of institutions.
Detailed description
Constitution differentiation is important for the prescription of Chinese medicines. In previous studies, researchers usually used constitutional questionnaires to determine constitutions.However, the importance of tongue diagnosis and pulse diagnosis remained unclear. The specific aim of this study is to evaluation indices of tongue diagnosis, auscultative diagnosis, and pulse diagnosis in the determination of constitutions. Meeting of specialists will determine the characteristics for each constitution first. This study plans to recruit 200 volunteers and determine their constitutions by constitutional questionnaires. Tongue manifestations and pulse pressure waveforms will be taken at the same time by standardized instruments. Relations between the indices and each constitution will be determined by multiple linear regression and logistic regression analysis. Then the percentage of importance of a specific index in a specific constitutional type could be determine.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| normal | – | Diagnostic Test: Pulse, tongue image, and voice soundA normal constitution condition in TCM. |
| Qi deficiency | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
| Damp heat | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
| Yang deficiency | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
| Yin deficiency | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
| Phlagm | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
| Blood stasis | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
| Qi stagnation | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
| Special | – | Diagnostic Test: Pulse, tongue image, and voice soundOne of an abnormal constitution condition in TCM. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- aged older than 20 years old
Key inclusion criteria (1 listed)
- Volunteers without aged older than 20 years old
Key exclusion criteria (3 listed)
- Pregnant
- taking any medicine currently
- suffering for acute disease currently
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 |
|---|---|---|
| Pulse, tongue image, and voice soundThey are four diagnosis methods of TCM | Diagnostic test | Blood stasis, Damp heat, Phlagm, Qi deficiency, Qi stagnation, Special, Yang deficiency, Yin deficiency, normal |
Primary outcome
Tongue image
Time frame: The photograph will be taken only at the first day the subject has been recruited
A photograph of tongue will be taken and the RGB color values of the tongue will be analyzed using Photoshop software
2 secondary outcomes
Acoustic sound
Time frame: The voice waves will be taken only once at the first day the subject has been recruited
Pulse image
Time frame: The pulse waveforms will be recorded at the first day the subject has been recruited
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 31 Aug 2018.
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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 Non-disease State, 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 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 31 Aug 2018. 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?
Tongue image (time frame: The photograph will be taken only at the first day the subject has been recruited). 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 31 Aug 2018.