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Tongue Diagnosis in Chronic Kidney Disease

Tongue Inspection and Diagnosis for Chronic Kidney Disease: Protocol for a Cross-sectional, Case-controlled Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04559958
Enrollment
120
Registered
2020-09-23
Start date
2018-09-01
Completion date
2020-08-31
Last updated
2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

Chronic kidney diseases, Automatic tongue diagnosis system, Traditional Chinese medicine

Brief summary

The Automatic Tongue Diagnosis System (ATDS) was developed to capture tongue images and extract features reliably to assist the diagnosis of traditional chinese medicine (TCM) practitioners.This project will employ the ATDS verified to extract the tongue features of patients with chronic kidney disease. 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 chronic kidney disease.

Detailed description

Chronic kidney disease (CKD) is a global financial and medical burden, because its high morbidity and mortality. Tongue diagnosis is an important diagnostic tool in traditional Chinese medicine. However, tongue diagnosis often biased by subjective judgements and environmental factors. The automatic tongue diagnosis system can noninvasively capture tongue images, automatically correct any lighting and color deviation and analyze tongue manifestations. This protocol is a cross-sectional, case-controlled observational study investigating the tongue features of non-dialysis CKD and end-stage renal disease patients by using the noninvasive ATDS. CKD patients who meets inclusion and exclusion criteria will be enrolled. Participants will be divided into 3 groups according to their renal function and accept dialysis or not, including a non-dialysis CKD group, end stage renal disease (ESRD) group and control group. Tongue images will be captured and 9 tongue features including tongue shape, tongue color, fur thickness, fur color, saliva, tongue fissure, ecchymosis, tooth mark, and red dots will be extracted and analyzed by ATDS. This protocol aims to apply noninvasive ATDS to analyze tongue features of CKD patients.

Interventions

DIAGNOSTIC_TESTtongue image

capture tongue images by Automatic Tongue Diagnosis System

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

The patients will be included if they meet the following criteria: 1. age over 20 years old 2. The person who volunteered to participate this research and signed the agreement of institutional review board.

Exclusion criteria

1. Pregnant women 2. Patients with acute infection 3. The person who has cancer with brain metastasis and present with cognitive dysfunction such as dementia or delirium 4. unable to protrude the tongue stably 5. Patients with risk of temporomandibular joint dislocation 6. Those who did not sign the agreement of institutional review board

Design outcomes

Primary

MeasureTime frameDescription
Tongue featuresday 1diagnosed by the Automatic Tongue Diagnosis System (ATDS)

Secondary

MeasureTime frameDescription
serum blood urea nitrogen (BUN)day 1renal function test
serum creatinineday 1renal function test
eGFRday 1eGFR is calculated by using the Modification of Diet in Renal Disease Study equation
hemoglobinday 1evaluate anemia

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026