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Chronic Kidney DiseasesNCT04559958

Tongue Diagnosis in Chronic Kidney Disease

An observational study of Chronic Kidney Diseases, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 traditional chinese medicine (TCM) practitioners.This project will employ the ATDS verified to extract the tongue features of patients with chronic kidney disease. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
tongue image
How many people
120 participants
Where
1 siteTaiwan
Study dates
1 Sep 2018to 31 Aug 2020
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: Patients with chronic kidney diseases

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
tongue image
Keywords
Chronic kidney diseases, Automatic tongue diagnosis system, Traditional Chinese medicine
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • tongue imageDiagnostic test

    capture tongue images by Automatic Tongue Diagnosis System

Study groups in NCT04559958
Study groupRoleWhat they receive
non-dialysis CKD groupParticipants 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.
Receives: Diagnostic Test: tongue image
ESRD groupParticipants with eGFR ≤15 mL/min/1.73 m2 and underwent regular dialysis will be recruited in ESRD group.
Receives: Diagnostic Test: tongue image
control groupParticipants 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.
Receives: Diagnostic Test: tongue image

What is being measured

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

  1. Tongue features

    diagnosed by the Automatic Tongue Diagnosis System (ATDS)

    Measured: day 1

Secondary outcomes (4)

  1. serum blood urea nitrogen (BUN)

    renal function test

    Measured: day 1

  2. serum creatinine

    renal function test

    Measured: day 1

  3. eGFR

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

    Measured: day 1

  4. hemoglobin

    evaluate anemia

    Measured: day 1

Timeline

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

  1. First posted23 Sep 2020
  2. Study start1 Sep 2018
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

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
Case-control
Time perspective
Cross-sectional
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559958
Sponsor's protocol ID
CMPRG8H0691
Status last verified
Sep 2018
First submitted
14 Sep 2020
Last updated
23 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsai MH, Hsu CY, Lin MY, Yen MF, Chen HH, Chiu YH, Hwang SJ. Incidence, Prevalence, and Duration of Chronic Kidney Disease in Taiwan: Results from a Community-Based Screening Program of 106,094 Individuals. Nephron. 2018;140(3):175-184. doi: 10.1159/000491708. Epub 2018 Aug 23.

    PubMed 30138926

  • Hsu PC, Wu HK, Huang YC, Chang HH, Lee TC, Chen YP, Chiang JY, Lo LC. The tongue features associated with type 2 diabetes mellitus. Medicine (Baltimore). 2019 May;98(19):e15567. doi: 10.1097/MD.0000000000015567.

    PubMed 31083226

  • 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, Cheng TL, Chen YJ, Natsagdorj S, Chiang JY. TCM tongue diagnosis index of early-stage breast cancer. Complement Ther Med. 2015 Oct;23(5):705-13. doi: 10.1016/j.ctim.2015.07.001. Epub 2015 Jul 10.

    PubMed 26365451

  • Kim J, Han G, Ko SJ, Nam DH, Park JW, Ryu B, Kim J. Tongue diagnosis system for quantitative assessment of tongue coating in patients with functional dyspepsia: a clinical trial. J Ethnopharmacol. 2014 Aug 8;155(1):709-13. doi: 10.1016/j.jep.2014.06.010. Epub 2014 Jun 13.

    PubMed 24933221

  • Levin A, Stevens PE. Summary of KDIGO 2012 CKD Guideline: behind the scenes, need for guidance, and a framework for moving forward. Kidney Int. 2014 Jan;85(1):49-61. doi: 10.1038/ki.2013.444. Epub 2013 Nov 27.

    PubMed 24284513

  • Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

    PubMed 10075613

  • Drawz P, Rahman M. Chronic kidney disease. Ann Intern Med. 2015 Jun 2;162(11):ITC1-16. doi: 10.7326/AITC201506020.

    PubMed 26030647

  • Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.

    PubMed 17898101

  • Almeras C, Argiles A. The general picture of uremia. Semin Dial. 2009 Jul-Aug;22(4):329-33. doi: 10.1111/j.1525-139X.2009.00575.x.

    PubMed 19708976

  • Zhong Y, Deng Y, Chen Y, Chuang PY, Cijiang He J. Therapeutic use of traditional Chinese herbal medications for chronic kidney diseases. Kidney Int. 2013 Dec;84(6):1108-18. doi: 10.1038/ki.2013.276. Epub 2013 Jul 17.

    PubMed 23868014

  • Zhong Y, Menon MC, Deng Y, Chen Y, He JC. Recent Advances in Traditional Chinese Medicine for Kidney Disease. Am J Kidney Dis. 2015 Sep;66(3):513-22. doi: 10.1053/j.ajkd.2015.04.013. Epub 2015 May 23.

    PubMed 26015275

  • Xiong W, He FF, You RY, Xiong J, Wang YM, Zhang C, Meng XF, Su H. Acupuncture Application in Chronic Kidney Disease and its Potential Mechanisms. Am J Chin Med. 2018;46(6):1169-1185. doi: 10.1142/S0192415X18500611.

    PubMed 30286626

  • Tania MH, Lwin K, Hossain MA. Advances in automated tongue diagnosis techniques. Integr Med Res. 2019 Mar;8(1):42-56. doi: 10.1016/j.imr.2018.03.001. Epub 2018 Mar 8.

    PubMed 30949431

  • Liu Q, Yue XQ, Ling CQ. [Researches into the modernization of tongue diagnosis: in retrospect and prospect]. Zhong Xi Yi Jie He Xue Bao. 2003 May;1(1):66-70. doi: 10.3736/jcim20030128. Chinese.

    PubMed 15339625

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases, run by Chang Gung Memorial Hospital 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 6 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: finished, as of the sponsor's last update on 23 Sep 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tongue features (time frame: day 1). 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 NCT04559958, which also lists 18 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 23 Sep 2020.

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