Tongue Diagnosis in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Tongue Inspection and Diagnosis for Chronic Kidney Disease: Protocol for a Cross-sectional, Case-controlled Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559958
• Other study ID #: CMPRG8H0691
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• tongue image
capture tongue images by Automatic Tongue Diagnosis System

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (18)

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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. Erratum in: Altern Ther Health Med. 2009 Jul-Aug;15(4):10. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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) — View Citation

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. Review. — View Citation

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. Review. Chinese. — View Citation

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. — View Citation

Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. Review. — View Citation

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. Review. — View Citation

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: 10.1159/00049 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tongue features	diagnosed by the Automatic Tongue Diagnosis System (ATDS)	day 1
Secondary	serum blood urea nitrogen (BUN)	renal function test	day 1
Secondary	serum creatinine	renal function test	day 1
Secondary	eGFR	eGFR is calculated by using the Modi?cation of Diet in Renal Disease Study equation	day 1
Secondary	hemoglobin	evaluate anemia	day 1

External Links

•   2019 Annual Report on Kidney Disease in Taiwan.