TCM Tongue Diagnosis Indices of UGI Disorders

September 17, 2020 updated by: hung yu chiang, Chang Gung Memorial Hospital

The Traditional Chinese Medicine (TCM) Tongue Diagnosis Indices of Upper Gastrointestinal (UGI) Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upper gastrointestinal disorders are common in clinical practice. Currently, the diagnosis of peptic ulcer only depends on laboratory exams such as clinical symptoms, blood test, urine test and feces test. But the result can be only auxiliary exams which don't gain correct diagnosis on helping assess ulcer severity. As the most suitable diagnosis method, panendoscopy can directly observe lesions, judge disease severity, carry out a biopsy, test lesion is benignant or malignant, Helicobacter Pylorus infection or not, the degree of inflammation, etc. But panendoscopy belongs to invasive test. If we can observe tongue characteristics of patients with upper gastrointestinal diseases through scientific tongue diagnosis, physical discomfort caused by the test will be significantly reduced.

Based on clinical observational study, this project will employ the Automatic Tongue Diagnosis System (ATDS) developed. The ATDS was developed to capture tongue images and extract features reliably to assist the diagnosis of TCM practitioners demonstrates the steps in the three major functions, i.e., image capturing and color calibration, tongues area segmentation, and tongue feature extraction, included in the ATDS.

Variations in background lighting may change the color and brightness of the acquired images, greatly affecting consistency and stability of the extracted tongue features. The ATDS developed can automatically correct lighting and color deviation caused by the change of background lighting with a color bar attached in the ATDS. The color bar placed beside the patient is used for color calibration to make sure the image quality is consistent even taken at different circumstances. Tongue images are analyzed by first isolating the tongue region within an image to eliminate irrelevant lower facial portions and background surrounding the tongue, thereby facilitating feature identification and extraction; and then extracting the tongue features by employing criteria such as the aspect ratio, color composition, location, shape, and color distribution of the tongue, as well as the quantity of neighboring pixels. Features including tongue color, tongue fissure, fur color, fur thickness, ecchymosis, tooth mark, red dot, saliva, and tongue shape are extracted to further generate detailed information regarding length, area, moisture, and number of fissures, marks, and dots to be employed in tongue diagnosis. Nine primary tongue features, including tongue color (slightly white, slightly red, red, dark red, dark purple), fur color (white, yellow, dye), fur thickness (none, thin, thick), saliva (none, little, normal, excessive), tongue shape (thin and small, moderate, fat and large), tongue fissure, red dot, ecchymosis, and tooth marks (the last four features are divided into categories of none, mild, moderate, and severe), are selected for tongue diagnosis.

This project will employ the ATDS verified to extract the tongue features of patients with upper gastrointestinal disorders. Through statistically analysis of the data collected and cross-referencing the existing indices of western medicine, we aim to derive meaningful TCM indices from tongue diagnosis of upper gastrointestinal diseases, 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.

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with upper gastrointestinal disorders

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: panendoscopy
panendoscopy
Diagnostic test: tongue image
capture tongue images by Automatic Tongue Diagnosis System
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: panendoscopy
panendoscopy
Diagnostic test: tongue image
capture tongue images by Automatic Tongue Diagnosis System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tongue features
Time Frame: 5-10 mins
diagnosed by the Automatic Tongue Diagnosis System (ATDS)
5-10 mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Panendoscopy report
Time Frame: 20-30 mins
diagnosed upper GI disorders by panendoscopy
20-30 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Sun Yat-sen University

Investigators

  • Principal Investigator: yu-chiang hung, Ph.D., Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

December 31, 2017

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (ACTUAL)

August 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-4725B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Upper Gastrointestinal Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe