NCT04708743

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

January 11, 2021

Last Update Submit

January 13, 2021

Conditions

CKD

Keywords

ATDS,Tongue Features

Outcome Measures

Primary Outcomes (1)

  • Tongue features

    capture tongue images by Automatic Tongue Diagnosis System(ATDS)

    5 mins

Study Arms (2)

CKD group

patients with CKD stage 3-5 including dialysis, followed tongue images by Automatic Tongue Diagnosis System

Diagnostic Test: Automatic Tongue Diagnosis System

Health group

patients who had no past history or systemic disease, CKD followed tongue images by Automatic Tongue Diagnosis System

Diagnostic Test: Automatic Tongue Diagnosis System

Interventions

Automatic Tongue Diagnosis SystemDIAGNOSTIC_TEST

tongue image capture tongue images by Automatic Tongue Diagnosis System

CKD groupHealth group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with CKD stage3-5

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Chinese Medicine, China Medical University

Taichung, Taiwan

RECRUITING

Related Publications (7)

  • 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.

    PMID: 24716178RESULT

  • 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.

    PMID: 23024693RESULT

  • 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: 27313640RESULT

  • 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.

    PMID: 24311851RESULT

  • 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.

    PMID: 22924055RESULT

  • 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.

    PMID: 24159343RESULT

  • 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.

    PMID: 33655979DERIVED

Study Officials

  • Lun-Chien Lo, phd

    School of Chinese Medicine, China Medical University, Taichung, Taiwan.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia-Ming Chen, master

CONTACT

+88647238595149353@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 14, 2021

Study Start

May 19, 2019

Primary Completion

January 30, 2021

Study Completion

April 20, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)