The Tongue Features Associated With Chronic Kidney Disease
NCT ID: NCT04708743
Last Updated: 2021-01-15
Study Results
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Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2019-05-19
2021-04-20
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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CKD group
patients with CKD stage 3-5 including dialysis, followed tongue images by Automatic Tongue Diagnosis System
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
Automatic Tongue Diagnosis System
tongue image capture tongue images by Automatic Tongue Diagnosis System
Interventions
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Automatic Tongue Diagnosis System
tongue image capture tongue images by Automatic Tongue Diagnosis System
Eligibility Criteria
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Inclusion Criteria
* CKD group:CKD stage 3-5 including dialysis patients
* Healthy group: without any medical history
Exclusion Criteria
* acute infection;
* unable to protrude the tongue stably;
* risk of temporomandibular joint dislocation.
20 Years
ALL
Yes
Sponsors
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China Medical University, Taiwan
OTHER
Responsible Party
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Jia-Ming Chen
Principal Investigator
Principal Investigators
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Lun-Chien Lo, phd
Role: PRINCIPAL_INVESTIGATOR
School of Chinese Medicine, China Medical University, Taichung, Taiwan.
Locations
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School of Chinese Medicine, China Medical University
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CCH
Identifier Type: -
Identifier Source: org_study_id
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