Tongue Diagnosis in Chronic Kidney Disease

September 21, 2020 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic kidney diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-dialysis CKD group
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.
Diagnostic test: tongue image
capture tongue images by Automatic Tongue Diagnosis System
ESRD group
Participants with eGFR ≤15 mL/min/1.73 m2 and underwent regular dialysis will be recruited in ESRD group.
Diagnostic test: tongue image
capture tongue images by Automatic Tongue Diagnosis System
control group
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.
Diagnostic test: tongue image
capture tongue images by Automatic Tongue Diagnosis System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tongue features
Time Frame: day 1
diagnosed by the Automatic Tongue Diagnosis System (ATDS)
day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: yu-chiang hung, Ph.D., Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

August 31, 2020

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (ACTUAL)

September 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMPRG8H0691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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