Tongue Diagnosis in Chronic Kidney Disease

NCT04559958 | Completed

• 1 other identifier: CMPRG8H0691
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

Chronic kidney diseases; Automatic tongue diagnosis system; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Tongue features

  diagnosed by the Automatic Tongue Diagnosis System (ATDS)

  day 1

Secondary Outcomes (4)

• serum blood urea nitrogen (BUN)

  day 1

• serum creatinine

  day 1

• eGFR

  day 1

• hemoglobin

  day 1

Study Arms (3)

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

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

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

Interventions

tongue image DIAGNOSTIC_TEST

capture tongue images by Automatic Tongue Diagnosis System

ESRD group; control group; non-dialysis CKD group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic kidney diseases

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (18)

• 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.

  PMID: 30138926 RESULT

• 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.

  PMID: 31083226 RESULT

• 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.

  PMID: 27313640 RESULT

• 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.

  PMID: 26365451 RESULT

• 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.

  PMID: 24933221 RESULT

• 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.

  PMID: 24284513 RESULT

• 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.

  PMID: 10075613 RESULT

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

  PMID: 26030647 RESULT

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

  PMID: 17898101 RESULT

• 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.

  PMID: 19708976 RESULT

• 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.

  PMID: 23868014 RESULT

• 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.

  PMID: 26015275 RESULT

• 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.

  PMID: 30286626 RESULT

• 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.

  PMID: 30949431 RESULT

• 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.

  PMID: 15339625 RESULT

• Anastasi JK, Currie LM, Kim GH. Understanding diagnostic reasoning in TCM practice: tongue diagnosis. Altern Ther Health Med. 2009 May-Jun;15(3):18-28.

  PMID: 19472861 RESULT

• Jung CJ, Jeon YJ, Kim JY, Kim KH. Review on the current trends in tongue diagnosis systems. Integr Med Res. 2012 Dec;1(1):13-20. doi: 10.1016/j.imr.2012.09.001. Epub 2012 Oct 5.

  PMID: 28664042 RESULT

• Chiu CC. A novel approach based on computerized image analysis for traditional Chinese medical diagnosis of the tongue. Comput Methods Programs Biomed. 2000 Feb;61(2):77-89. doi: 10.1016/s0169-2607(99)00031-0.

  PMID: 10661393 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• yu-chiang hung, Ph.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 23, 2020
• Study Start: September 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 23, 2020

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)