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Evaluation on the Availability of Tongue Diagnosis System

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ClinicalTrials.gov Identifier: NCT01864837
Recruitment Status : Unknown
Verified May 2013 by Jin-sung Kim, Korea Health Industry Development Institute.
Recruitment status was:  Recruiting
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Jin-sung Kim, Korea Health Industry Development Institute

Brief 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).

Condition or disease
Tongue Coating Thickness

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
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
Study Start Date : February 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Group/Cohort
Functional dyspepsia
They should meet the Rome III criteria for functional dyspepsia.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. tongue coating thickness(TCT) by the five clinicians [ Time Frame: After completing the collection of 60 patients' tongue images ]
    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.

  2. the weight of tongue coating [ Time Frame: 2nd visit (1st visit is for screening) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 patients with functional dyspepsia which be considered to appear the various aspects of tongue coating in traditional Korean medicine(TKM).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864837


Contacts
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Contact: Jinsung Kim, doctorate +82-2-958-8895 oridoc@khu.ac.kr

Locations
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Korea, Republic of
Kyung Hee University Korean Medicine Hospital Recruiting
Seoul, Korea, Republic of, 130-872
Contact: Jinsung Kim, doctorate    +82-2-958-8895    oridoc@khu.ac.kr   
Principal Investigator: Jinsung Kim, doctorate         
Sponsors and Collaborators
Korea Health Industry Development Institute
Investigators
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Principal Investigator: Jinsung Kim Kim, doctorate Kyung Hee University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin-sung Kim, Full professor, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT01864837     History of Changes
Other Study ID Numbers: KOMCIRB-2013-01
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Keywords provided by Jin-sung Kim, Korea Health Industry Development Institute:
tongue coating thickness
tongue diagnosis system
tongue coating percentage
availability
diagnostic device