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OpenTrials
Completed

NCT Number: NCT04559958

Tongue Diagnosis in Chronic Kidney Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patients will be included if they meet the following criteria:

  • age over 20 years old
  • The person who volunteered to participate this research and signed the agreement of institutional review board.

Exclusion criteria

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

Treatment and study plan

tongue image

Diagnostic Test

capture tongue images by Automatic Tongue Diagnosis System

Primary outcomes

  1. Tongue features

    Time frame: day 1

    diagnosed by the Automatic Tongue Diagnosis System (ATDS)

Secondary outcomes

  1. serum blood urea nitrogen (BUN)

    Time frame: day 1

    renal function test

  2. serum creatinine

    Time frame: day 1

    renal function test

  3. eGFR

    Time frame: day 1

    eGFR is calculated by using the Modification of Diet in Renal Disease Study equation

  4. hemoglobin

    Time frame: day 1

    evaluate anemia

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2020
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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