Clinical trial NCT01864837: Evaluation on the Availability of Tongue Diagnosis System
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tongue Coating Thickness
Keywords: tongue coating thickness
tongue diagnosis system
tongue coating percentage
availability
diagnostic device
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2013-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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).

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).

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.

Eligibility 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

Primary outcomes:
measure: tongue coating thickness(TCT) by tongue diagnosis system
timeFrame: 2nd visit (1st visit is for screening)
Secondary outcomes:
measure: tongue coating thickness(TCT) by the five clinicians
timeFrame: After completing the collection of 60 patients' tongue images
measure: the weight of tongue coating
timeFrame: 2nd visit (1st visit is for screening)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Jinsung Kim Kim, doctorate
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.