Clinical trial NCT04559958: Tongue Diagnosis in Chronic Kidney Disease
Official title: Tongue Inspection and Diagnosis for Chronic Kidney Disease: Protocol for a Cross-sectional, Case-controlled Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: Chronic kidney diseases
Automatic tongue diagnosis system
Traditional Chinese medicine
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney diseases

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tongue features
timeFrame: day 1
Secondary outcomes:
measure: serum blood urea nitrogen (BUN)
timeFrame: day 1
measure: serum creatinine
timeFrame: day 1
measure: eGFR
timeFrame: day 1
measure: hemoglobin
timeFrame: day 1
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: yu-chiang hung, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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