The Tongue Features Associated With Chronic Kidney Disease

January 13, 2021 updated by: Jia-Ming Chen, China Medical University, Taiwan
The Automatic Tongue Diagnosis System (ATDS) was developed to capture tongue images and extract features reliably to assist the diagnosis of TCM practitioners.This project will employ the ATDS verified to extract the tongue features of patients with chronic kidney disease(CKD) including dialysis patients. 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 CKD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease (CKD) is an important global public health problem. According to related literatures, the prevalence of CKD is about 11% .CKD is a progressive disease. If it progresses to end-stage renal disease (ESRD), renal replacement therapy: dialysis and renal transplantation, is required to maintain life. The growing prevalence and progression of chronic kidney disease (CKD) raises concerns about our capacity to manage its economic burden to patients, caregivers, and society. The societal direct and indirect costs of CKD and end-stage renal disease are substantial and increase throughout disease progression. There is significant variability in the evidence about direct and indirect costs attributable to CKD and end-stage renal disease, with the most complete evidence concentrated on direct health care costs of patients with advanced to end-stage CKD.

CKD, also called chronic kidney failure, is described as a sustained reduction in glomerular filtration rate or evidence of structural or functional kidney abnormalities.Chronic kidney disease (CKD) refers to all five stages of kidney damage, from very mild damage in stage 1 to complete kidney failure in stage 5. CKD symptoms include pain, itch(pruritus), peripheral numbness, sleep disturbances, depression, fatigue, nausea and vomiting. Factors that contribute to these symptoms include anaemia, uraemic toxins, reduced renal capacity, chronic disease-related inflammation, and psychological stress associated with long-term illness.If it progresses to end-stage renal disease (ESRD), renal replacement therapy, including hemodialysis, peritoneal dialysis and kidney transplantation, is required to maintain life. Therefore, it is essential to find effective and conservative treatment methods to delay the progression of CKD.

Diagnosis in traditional Chinese medicine (TCM) is based on four procedures, observation, smelling or listening, inquiry, and palpation. Tongue diagnosis, serving as a vital non-invasive tool to provide useful clinical information, plays a pivotal role in TCM. The tongue is considered to reflect the physiological and pathological condition of the body, as well as the degree and progression of disease, through the meridians that connect the tongue to the internal organs.By observing tongue features, TCM practitioners can probe qi-blood, yin-yang disorders which are important in treatment selection and prognosis.Clinically, practitioners observe tongue characteristics, such as tongue color and shape, fur color and thickness, and the amount of saliva, to help deduce the primary pattern of a patient. However, tongue diagnosis is often biased by subjective judgment, which originates from personal experience, knowledge, diagnostic skills, thinking patterns, and color perception/interpretation.The inconsistency of subjective diagnosis can be improved by using the development of validated instruments. The automatic tongue diagnosis system (ATDS) has shown high consistency and can provide objective and reliable information and analysis of tongue features, facilitating doctors in making effective observations and diagnoses of specific diseases.Previous studies have been conducted on exploring the association between tongue characteristics and specific diseases, including rheumatoid arthritis, breastcancer,type 2 diabetes, metabolic syndrome, eczema, dysmenorrhea and functional dyspepsia, gastroesophageal reflux disease.However, to the best of our knowledge, no study has yet been performed on the comprehensive scrutiny of tongue features in patients with CKD using ATDS.

The objectives of this protocol are to apply the noninvasive ATDS to evaluate tongue manifestations in patients with CKD, and to provide valuable information for clinical doctors, which can be used to facilitate the early detection and diagnosis of CKD, to analyze the current status of patients, and to dynamically schedule treatment plans.

Study Type

Observational

Enrollment (Anticipated)

400

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
      • Taichung, Taiwan
        • Recruiting
        • School of Chinese Medicine, China Medical University
        • Contact:
        • Principal Investigator:
          • Lun-Chien Lo, phd

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

Subjects with CKD stage3-5

Description

Inclusion Criteria:

  • age over 20 years old;
  • CKD group:CKD stage 3-5 including dialysis patients
  • Healthy group: without any medical history

Exclusion Criteria:

  • cancer;
  • acute infection;
  • unable to protrude the tongue stably;
  • risk of temporomandibular joint dislocation.

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
CKD group
patients with CKD stage 3-5 including dialysis, followed tongue images by Automatic Tongue Diagnosis System
Diagnostic test: Automatic Tongue Diagnosis System
tongue image capture tongue images by Automatic Tongue Diagnosis System
Health group
patients who had no past history or systemic disease, CKD followed tongue images by Automatic Tongue Diagnosis System
Diagnostic test: Automatic Tongue Diagnosis System
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: 5 mins
capture tongue images by Automatic Tongue Diagnosis System(ATDS)
5 mins

Collaborators and Investigators

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

Sponsor

China Medical University, Taiwan

Investigators

  • Principal Investigator: Lun-Chien Lo, phd, School of Chinese Medicine, China Medical University, Taichung, Taiwan.

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)

May 19, 2019

Primary Completion (ANTICIPATED)

January 30, 2021

Study Completion (ANTICIPATED)

April 20, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCH

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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