NCT01864837

Evaluation on the Availability of Tongue Diagnosis System

Availability of Tongue Diagnosis System for Assessing Tongue Coating Thickness of Patients With Functional Dyspepsia: Study Protocol for Comparative Trial With Conventional Method

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Korea Health Industry Development Institute · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

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

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2013-05-30
• Last updated: 2013-05-30

Locations

1 site across 1 country: South Korea