TCM Tongue Diagnosis Indices of UGI Disorders

NCT ID: NCT03258216

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Upper Gastrointestinal Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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peptic ulcer

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

panendoscopy

Intervention Type DIAGNOSTIC_TEST

panendoscopy

tongue image

Intervention Type DIAGNOSTIC_TEST

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

panendoscopy

Intervention Type DIAGNOSTIC_TEST

panendoscopy

tongue image

Intervention Type DIAGNOSTIC_TEST

capture tongue images by Automatic Tongue Diagnosis System

Interventions

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panendoscopy

panendoscopy

Intervention Type DIAGNOSTIC_TEST

tongue image

capture tongue images by Automatic Tongue Diagnosis System

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Sun Yat-sen University

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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hung yu chiang

Director of Chinese Medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yu-chiang hung, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 24716178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23024693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24159343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10661393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27313640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24933221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24311851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22924055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26457297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28664042 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32702810 (View on PubMed)

Other Identifiers

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104-4725B

Identifier Type: -

Identifier Source: org_study_id

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