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Evaluation on the Availability of Tongue Diagnosis System

K

Korea Health Industry Development Institute

Status

Unknown

Conditions

Tongue Coating Thickness

Study type

Observational

Funder types

Other

Identifiers

NCT01864837
KOMCIRB-2013-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Functional dyspepsia
Description:
They should meet the Rome III criteria for functional dyspepsia.

Trial contacts and locations

1

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Central trial contact

Jinsung Kim, doctorate

Data sourced from clinicaltrials.gov

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