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CKDNCT04708743

The Tongue Features Associated With Chronic Kidney Disease

An observational study of CKD, run by China Medical University, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
CKD
What is being tested?
Automatic Tongue Diagnosis System
How many people
400 participants
Where
1 siteTaiwan
Study dates
19 May 2019to 20 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects with CKD stage3-5

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jia-Ming Chen, master contact

+88647238595 ext. 4026

149353@gmail.com

Taiwan1 site, 1 recruiting
  • School of Chinese Medicine, China Medical University

    Taichung

    Jia-Ming Chen, master, 149353@gmail.com

    Lun-Chien Lo, phd

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
CKD
Being tested
Automatic Tongue Diagnosis System
Keywords
ATDS,Tongue Features

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automatic Tongue Diagnosis SystemDiagnostic test

    tongue image capture tongue images by Automatic Tongue Diagnosis System

Study groups in NCT04708743
Study groupRoleWhat they receive
CKD grouppatients with CKD stage 3-5 including dialysis, followed tongue images by Automatic Tongue Diagnosis System
Receives: Diagnostic Test: Automatic Tongue Diagnosis System
Health grouppatients who had no past history or systemic disease, CKD followed tongue images by Automatic Tongue Diagnosis System
Receives: Diagnostic Test: Automatic Tongue Diagnosis System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tongue features

    capture tongue images by Automatic Tongue Diagnosis System(ATDS)

    Measured: 5 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2021
  2. Study start19 May 2019
  3. Primary completion30 Jan 2021 (estimated)
  4. Study completion20 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04708743
Sponsor's protocol ID
CCH
Status last verified
Jan 2021
First submitted
11 Jan 2021
Last updated
15 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lo LC, Cheng TL, Chiang JY, Damdinsuren N. Breast cancer index: a perspective on tongue diagnosis in traditional chinese medicine. J Tradit Complement Med. 2013 Jul;3(3):194-203. doi: 10.4103/2225-4110.114901.

    PubMed 24716178
  • Lo LC, Chiang JY, Cheng TL, Shieh PS. Visual agreement analyses of traditional chinese medicine: a multiple-dimensional scaling approach. Evid Based Complement Alternat Med. 2012;2012:516473. doi: 10.1155/2012/516473. Epub 2012 Sep 17.

    PubMed 23024693
  • Lee TC, Lo LC, Wu FC. Traditional Chinese Medicine for Metabolic Syndrome via TCM Pattern Differentiation: Tongue Diagnosis for Predictor. Evid Based Complement Alternat Med. 2016;2016:1971295. doi: 10.1155/2016/1971295. Epub 2016 May 25.

    PubMed 27313640
  • Lo LC, Chen CY, Chiang JY, Cheng TL, Lin HJ, Chang HH. Tongue diagnosis of traditional Chinese medicine for rheumatoid arthritis. Afr J Tradit Complement Altern Med. 2013 Aug 12;10(5):360-9. doi: 10.4314/ajtcam.v10i5.24. eCollection 2013.

    PubMed 24311851
  • Lo LC, Chen YF, Chen WJ, Cheng TL, Chiang JY. The Study on the Agreement between Automatic Tongue Diagnosis System and Traditional Chinese Medicine Practitioners. Evid Based Complement Alternat Med. 2012;2012:505063. doi: 10.1155/2012/505063. Epub 2012 Aug 8.

    PubMed 22924055
  • Kim J, Son J, Jang S, Nam DH, Han G, Yeo I, Ko SJ, Park JW, Ryu B, Kim J. Availability of tongue diagnosis system for assessing tongue coating thickness in patients with functional dyspepsia. Evid Based Complement Alternat Med. 2013;2013:348272. doi: 10.1155/2013/348272. Epub 2013 Sep 15.

    PubMed 24159343
  • Chen JM, Chiu PF, Wu FM, Hsu PC, Deng LJ, Chang CC, Chiang JY, Lo LC. The tongue features associated with chronic kidney disease. Medicine (Baltimore). 2021 Mar 5;100(9):e25037. doi: 10.1097/MD.0000000000025037.

    PubMed 33655979

Questions about this trial

What is this clinical trial studying?

An observational study of CKD, run by China Medical University, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jia-Ming Chen, master (+88647238595 ext. 4026, 149353@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tongue features (time frame: 5 mins). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04708743, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.

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