NCT03258216

Brief Summary

The Automatic Tongue Diagnosis System (ATDS) was developed to capture tongue images and extract features reliably to assist the diagnosis of TCM practitioners.This project will employ the ATDS verified to extract the tongue features of patients with upper gastrointestinal disorders, such as peptic ulcer, etc. A TCM indices derived through the non-intrusive tongue diagnosis procedure can provide valuable information for clinical doctors to analyze the current status of a patient and dynamically schedule a treatment plan, facilitating early detection and diagnosis of upper gastrointestinal disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

August 17, 2017

Last Update Submit

September 17, 2020

Conditions

Upper Gastrointestinal Disorders

Keywords

Upper gastrointestinal disordersAutomatic tongue diagnosis systemPanendoscopy

Outcome Measures

Primary Outcomes (1)

  • Tongue features

    diagnosed by the Automatic Tongue Diagnosis System (ATDS)

    5-10 mins

Secondary Outcomes (1)

  • Panendoscopy report

    20-30 mins

Study Arms (2)

peptic ulcer

patients who had upper GI symptoms and diagnosed as peptic ulcer by panendoscopy, followed tongue images by Automatic Tongue Diagnosis System

Diagnostic Test: panendoscopyDiagnostic Test: tongue image

healthy

patients who had no past history or systemic disease, diagnosed as UGI negative finding by panendoscopy, followed tongue images by Automatic Tongue Diagnosis System

Diagnostic Test: panendoscopyDiagnostic Test: tongue image

Interventions

panendoscopyDIAGNOSTIC_TEST

panendoscopy

healthypeptic ulcer
tongue imageDIAGNOSTIC_TEST

capture tongue images by Automatic Tongue Diagnosis System

healthypeptic ulcer

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with upper gastrointestinal disorders

You may qualify if:

  • Patients with upper gastrointestinal disorders
  • Both males and females above 20 years old were included
  • Patients who had signed Institutional Review Board (IRB) agreement

You may not qualify if:

  • Patients who had not signed IRB agreement
  • Patients who had hypertension, diabetes, hepatitis, or other systemic diseases
  • Pregnant women
  • Patient with acute infection
  • Cognitive impaired, for example, cancer metastasis to brain or dementia
  • Risk of temporomandibular joint dislocation
  • Patients unable to protrude the tongue stably

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (11)

  • Lo LC, Cheng TL, Chiang JY, Damdinsuren N. Breast cancer index: a perspective on tongue diagnosis in traditional chinese medicine. J Tradit Complement Med. 2013 Jul;3(3):194-203. doi: 10.4103/2225-4110.114901.

    PMID: 24716178BACKGROUND

  • Lo LC, Chiang JY, Cheng TL, Shieh PS. Visual agreement analyses of traditional chinese medicine: a multiple-dimensional scaling approach. Evid Based Complement Alternat Med. 2012;2012:516473. doi: 10.1155/2012/516473. Epub 2012 Sep 17.

    PMID: 23024693BACKGROUND

  • 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: 24159343BACKGROUND

  • Chiu CC. A novel approach based on computerized image analysis for traditional Chinese medical diagnosis of the tongue. Comput Methods Programs Biomed. 2000 Feb;61(2):77-89. doi: 10.1016/s0169-2607(99)00031-0.

    PMID: 10661393BACKGROUND

  • Lee TC, Lo LC, Wu FC. Traditional Chinese Medicine for Metabolic Syndrome via TCM Pattern Differentiation: Tongue Diagnosis for Predictor. Evid Based Complement Alternat Med. 2016;2016:1971295. doi: 10.1155/2016/1971295. Epub 2016 May 25.

    PMID: 27313640BACKGROUND

  • Kim J, Han G, Ko SJ, Nam DH, Park JW, Ryu B, Kim J. Tongue diagnosis system for quantitative assessment of tongue coating in patients with functional dyspepsia: a clinical trial. J Ethnopharmacol. 2014 Aug 8;155(1):709-13. doi: 10.1016/j.jep.2014.06.010. Epub 2014 Jun 13.

    PMID: 24933221BACKGROUND

  • Lo LC, Chen CY, Chiang JY, Cheng TL, Lin HJ, Chang HH. Tongue diagnosis of traditional Chinese medicine for rheumatoid arthritis. Afr J Tradit Complement Altern Med. 2013 Aug 12;10(5):360-9. doi: 10.4314/ajtcam.v10i5.24. eCollection 2013.

    PMID: 24311851BACKGROUND

  • Lo LC, Chen YF, Chen WJ, Cheng TL, Chiang JY. The Study on the Agreement between Automatic Tongue Diagnosis System and Traditional Chinese Medicine Practitioners. Evid Based Complement Alternat Med. 2012;2012:505063. doi: 10.1155/2012/505063. Epub 2012 Aug 8.

    PMID: 22924055BACKGROUND

  • Hu J, Han S, Chen Y, Ji Z. Variations of Tongue Coating Microbiota in Patients with Gastric Cancer. Biomed Res Int. 2015;2015:173729. doi: 10.1155/2015/173729. Epub 2015 Sep 17.

    PMID: 26457297BACKGROUND

  • Jung CJ, Jeon YJ, Kim JY, Kim KH. Review on the current trends in tongue diagnosis systems. Integr Med Res. 2012 Dec;1(1):13-20. doi: 10.1016/j.imr.2012.09.001. Epub 2012 Oct 5.

    PMID: 28664042BACKGROUND

  • Wu TC, Lu CN, Hu WL, Wu KL, Chiang JY, Sheen JM, Hung YC. Tongue diagnosis indices for gastroesophageal reflux disease: A cross-sectional, case-controlled observational study. Medicine (Baltimore). 2020 Jul 17;99(29):e20471. doi: 10.1097/MD.0000000000020471.

    PMID: 32702810DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • yu-chiang hung, Ph.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Chinese Medicine department

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 23, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)