Evaluation on the Availability of Tongue Diagnosis System

May 24, 2013 updated by: Jin-sung Kim, Korea Health Industry Development Institute

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinsung Kim, doctorate
  • Phone Number: +82-2-958-8895
  • Email: oridoc@khu.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 130-872
        • Recruiting
        • Kyung Hee University Korean Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Jinsung Kim, doctorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2nd visit (1st visit is for screening)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After completing the collection of 60 patients' tongue images
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).
2nd visit (1st visit is for screening)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Health Industry Development Institute

Investigators

  • Principal Investigator: Jinsung Kim Kim, doctorate, Kyung Hee University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 24, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOMCIRB-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tongue Coating Thickness

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe