Tongue Coating ThicknessNCT01864837
Evaluation on the Availability of Tongue Diagnosis System
An observational study of Tongue Coating Thickness, run by Korea Health Industry Development Institute at 1 site in South Korea.
Trial summary
The aim of the proposed study is to investigate the agreement between the measurement of the tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Tongue Coating Thickness
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Nov 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 60 patients with functional dyspepsia which be considered to appear the various aspects of tongue coating in traditional Korean medicine(TKM).
Who may be able to join
- Age 20 years or older
- One who meet the Rome III criteria for functional dyspepsia
- One who is able to read, write, hear, see something
- One who agree on consent form
Who cannot join
- Mental disorders
- Pregnancy
- Severe systemic organ diseases such as cancer
- Infectious or other serious consumptive diseases
- Geographic tongue
- One who cannot open his/her mouth or protrude his/her tongue
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Korean Medicine Hospital
Seoul, Seoul, 130-872
Jinsung Kim, doctorate, +82-2-958-8895, oridoc@khu.ac.kr
Jinsung Kim, doctorate
About this study
Official title: Availability of Tongue Diagnosis System for Assessing Tongue Coating Thickness of Patients With Functional Dyspepsia: Study Protocol for Comparative Trial With Conventional Method
The aim of the proposed study is to investigate the agreement between the measurement of the tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM).
Read the detailed description
Tongue diagnosis is one of the important diagnostic techniques to examine the physiologic functions and pathologic changes of the internal organs in TKM.
However, traditional tongue diagnosis has inevitable limitations because of the clinician's subjectivity and environmental factors influencing on the diagnostic results.
Therefore, it is necessary to investigate the availability of the tongue diagnosis system (TDS).
The aim of the this study is to investigate the agreement between the measurement of TDS and the conventional way of tongue diagnosis about TCT in the tongue diagnosis of TKM. So, we will assess the agreement between the measurement of TDS and the final diagnosis of 5 clinicians with five or more years of clinical experience about TCT.
Additionally, we will evaluate the reproducibility of TDS. In the 2nd visit, taking tongue images of each patient with TDS will be performed again at 30 minute-intervals in the same way. And then, we will compare the two TDS measurements of each patient about TCT.
After twice examination of TDS, the weight of tongue coating (mg) will be measured quantitatively by tongue scraping to analyze the correlation between the weight of tongue coating and the measurements of TDS.
In addition, after the collection of 60 patients' tongue images is completed, we will ascertain the validity of the five clinicians for diagnosing the TCT by assessing the inter-and intra-rater reliability of the five clinicians.
- Conditions
- Tongue Coating Thickness
- Keywords
- tongue coating thickness, tongue diagnosis system, tongue coating percentage, availability, diagnostic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Functional dyspepsia | They should meet the Rome III criteria for functional dyspepsia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
tongue coating thickness(TCT) by tongue diagnosis system
In the 2nd visit, Tongue coating thickness(TCT) will be assessed by tongue coating percentage(%)from TDS measurements. In the advanced study, 29.06% is a cut-off point to separate no coating and thin coating, and 63.51% is a cut-off point to separate thin coating and thick coating.
Measured: 2nd visit (1st visit is for screening)
Secondary outcomes (2)
tongue coating thickness(TCT) by the five clinicians
After the collection of 60 patients' tongue images is completed, 5 clinicians with five or more years of clinical experience will assess the TCT of 60 patients with 60 images obtained by TDS. In order to decide the final diagnosis of the 5 clinicians as a gold standard, if we have a disagreement among them, we will agree to the views of the majority.
Measured: After completing the collection of 60 patients' tongue images
the weight of tongue coating
The weight of tongue coating (mg); It will be measured quantitatively to analyze the correlation between the tongue coating percentage measured with TDS and the weight of tongue coating obtained by tongue scraping(Yaegaki's method).
Measured: 2nd visit (1st visit is for screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tongue Coating ThicknessStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Health Industry Development Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jin-sung Kim, Korea Health Industry Development Institute
- Investigators
- Jinsung Kim Kim, doctorate, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864837
- Sponsor's protocol ID
- KOMCIRB-2013-01
- Status last verified
- May 2013
- First submitted
- 22 May 2013
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim J, Son J, Jang S, Nam DH, Han G, Yeo I, Ko SJ, Park JW, Ryu B, Kim J. Availability of tongue diagnosis system for assessing tongue coating thickness in patients with functional dyspepsia. Evid Based Complement Alternat Med. 2013;2013:348272. doi: 10.1155/2013/348272. Epub 2013 Sep 15.
PubMed 24159343
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Availability of Tongue Diagnosis System for Assessing Tongue Coating Thickness of Patients With Functional Dyspepsia: Study Protocol for Comparative Trial With Conventional Method
- ClinicalTrials.gov ID
- NCT01864837
- Acronym / sponsor ID
- KOMCIRB-2013-01
- Conditions
- Tongue Coating Thickness
- Keywords
- tongue coating thickness, tongue diagnosis system, tongue coating percentage, availability, diagnostic device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Korea Health Industry Development InstituteOther government
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 30 May 2013 (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.
The aim of the proposed study is to investigate the agreement between the measurement of the tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM).
Detailed description
Tongue diagnosis is one of the important diagnostic techniques to examine the physiologic functions and pathologic changes of the internal organs in TKM.
However, traditional tongue diagnosis has inevitable limitations because of the clinician's subjectivity and environmental factors influencing on the diagnostic results.
Therefore, it is necessary to investigate the availability of the tongue diagnosis system (TDS).
The aim of the this study is to investigate the agreement between the measurement of TDS and the conventional way of tongue diagnosis about TCT in the tongue diagnosis of TKM. So, we will assess the agreement between the measurement of TDS and the final diagnosis of 5 clinicians with five or more years of clinical experience about TCT.
Additionally, we will evaluate the reproducibility of TDS. In the 2nd visit, taking tongue images of each patient with TDS will be performed again at 30 minute-intervals in the same way. And then, we will compare the two TDS measurements of each patient about TCT.
After twice examination of TDS, the weight of tongue coating (mg) will be measured quantitatively by tongue scraping to analyze the correlation between the weight of tongue coating and the measurements of TDS.
In addition, after the collection of 60 patients' tongue images is completed, we will ascertain the validity of the five clinicians for diagnosing the TCT by assessing the inter-and intra-rater reliability of the five clinicians.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia | – | –They should meet the Rome III criteria for functional dyspepsia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients with functional dyspepsia which be considered to appear the various aspects of tongue coating in traditional Korean medicine(TKM).
Key inclusion criteria (4 listed)
- Age 20 years or older
- One who meet the Rome III criteria for functional dyspepsia
- One who is able to read, write, hear, see something
- One who agree on consent form
Key exclusion criteria (6 listed)
- Mental disorders
- Pregnancy
- Severe systemic organ diseases such as cancer
- Infectious or other serious consumptive diseases
- Geographic tongue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tongue coating thickness(TCT) by tongue diagnosis system
Time frame: 2nd visit (1st visit is for screening)
In the 2nd visit, Tongue coating thickness(TCT) will be assessed by tongue coating percentage(%)from TDS measurements. In the advanced study, 29.06% is a cut-off point to separate no coating and thin coating, and 63.51% is a cut-off point to separate thin coating and thick coating.
2 secondary outcomes
tongue coating thickness(TCT) by the five clinicians
Time frame: After completing the collection of 60 patients' tongue images
the weight of tongue coating
Time frame: 2nd visit (1st visit is for screening)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Derived from this study: PubMed 24159343Kim J, Son J, Jang S, Nam DH, Han G, Yeo I, Ko SJ, Park JW, Ryu B, Kim J. Availability of tongue diagnosis system for assessing tongue coating thickness in patients with functional dyspepsia. Evid Based Complement Alternat Med. 2013;2013:348272. doi: 10.1155/2013/348272. Epub 2013 Sep 15.
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.
Jinsung Kim Kim, doctorate principal investigator
Kyung Hee University Hospital
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 Tongue Coating Thickness, run by Korea Health Industry Development Institute at 1 site in South Korea.
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 4 inclusion and 6 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 30 May 2013. 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 South Korea. 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 Jinsung Kim, doctorate (+82-2-958-8895, oridoc@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tongue coating thickness(TCT) by tongue diagnosis system (time frame: 2nd visit (1st visit is for screening)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864837, which also lists 1 linked publication.
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 30 May 2013.