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TCM Tongue Diagnosis Indices of UGI Disorders

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ClinicalTrials.gov Identifier: NCT03258216
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
National Sun Yat-sen University
Information provided by (Responsible Party):
hung yu chiang, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment
Upper Gastrointestinal Disorders Diagnostic Test: panendoscopy Diagnostic Test: tongue image

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
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Traditional Chinese Medicine (TCM) Tongue Diagnosis Indices of Upper Gastrointestinal (UGI) Disorders
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Tongue features [ Time Frame: 5-10 mins ]
    diagnosed by the Automatic Tongue Diagnosis System (ATDS)


Secondary Outcome Measures :
  1. Panendoscopy report [ Time Frame: 20-30 mins ]
    diagnosed upper GI disorders by panendoscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with upper gastrointestinal disorders
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258216


Contacts
Contact: yu-chiang hung, Ph.D. +88677317123 ext 2334 hungyuchiang@gmail.com
Contact: tzu-chan wu, Dr. +886975056784 tzuchanwu@gmail.com

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: yu-chiang Hung, PhD    +886-77317123 ext 2334    hungyuchiang@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Sun Yat-sen University
Investigators
Principal Investigator: yu-chiang hung, Ph.D. Chang Gung Memorial Hospital

Publications:

Responsible Party: hung yu chiang, Director of Chinese Medicine department, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03258216     History of Changes
Other Study ID Numbers: 104-4725B
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hung yu chiang, Chang Gung Memorial Hospital:
Upper gastrointestinal disorders
Automatic tongue diagnosis system
Panendoscopy

Additional relevant MeSH terms:
Disease
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes