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
1 other identifier
observational
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 30, 2013
May 1, 2013
7 months
May 22, 2013
May 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tongue coating thickness(TCT) by tongue diagnosis system
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 Outcomes (2)
tongue coating thickness(TCT) by the five clinicians
After completing the collection of 60 patients' tongue images
the weight of tongue coating
2nd visit (1st visit is for screening)
Study Arms (1)
Functional dyspepsia
They should meet the Rome III criteria for functional dyspepsia.
Eligibility Criteria
60 patients with functional dyspepsia which be considered to appear the various aspects of tongue coating in traditional Korean medicine(TKM).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University Korean Medicine Hospital
Seoul, Seoul, 130-872, South Korea
Related Publications (1)
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.
PMID: 24159343DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jinsung Kim Kim, doctorate
Kyung Hee University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full professor
Study Record Dates
First Submitted
May 22, 2013
First Posted
May 30, 2013
Study Start
February 1, 2013
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
May 30, 2013
Record last verified: 2013-05