Tongue Diagnosis in Chronic Kidney Disease

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04559958
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Diagnostic Test: tongue image

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 Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Tongue Inspection and Diagnosis for Chronic Kidney Disease: Protocol for a Cross-sectional, Case-controlled Observational Study
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Tongue features [day 1]

   diagnosed by the Automatic Tongue Diagnosis System (ATDS)

Secondary Outcome Measures

1. serum blood urea nitrogen (BUN) [day 1]

   renal function test

2. serum creatinine [day 1]

   renal function test

3. eGFR [day 1]

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

4. hemoglobin [day 1]

   evaluate anemia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	833

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04559958
• Other Study ID Numbers: CMPRG8H0691
• First Posted: Sep 23, 2020
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chang Gung Memorial Hospital: Chronic kidney diseases; Automatic tongue diagnosis system; Traditional Chinese medicine
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Sep 23, 2020