Tongue Diagnosis in Chronic Kidney Disease

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Diagnostic Test: tongue image

• Registration Number: NCT04559958
• Lead Sponsor: 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 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.

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-dialysis CKD group	tongue image	Participants with estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 more than three months and without regular dialysis will be enrolled in non-dialysis CKD group.
ESRD group	tongue image	Participants with eGFR ≤15 mL/min/1.73 m2 and underwent regular dialysis will be recruited in ESRD group.
control group	tongue image	Participants with eGFR ≧60 mL/min/1.73 m2 and without evidence of kidney damage such as albuminuria or abnormal findings on renal imaging will be enrolled in control group.

Primary Outcome Measures

Name	Time	Method
Tongue features	day 1	diagnosed by the Automatic Tongue Diagnosis System (ATDS)

Secondary Outcome Measures

Name	Time	Method
serum blood urea nitrogen (BUN)	day 1	renal function test
eGFR	day 1	eGFR is calculated by using the Modification of Diet in Renal Disease Study equation
hemoglobin	day 1	evaluate anemia
serum creatinine	day 1	renal function test

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan