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NCT05563090

Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools

Completed Last updated 4 May 2025
What this trial tests

trial testing Questionnaires+Tongue diagnosis+Pulse diagnosis in Diabete Mellitus in 171 participants. Completed in 1 April 2025.

Timeline
17 September 2022
Primary endpoint
1 April 2025
1 April 2025

Quick facts

Lead sponsorSingapore Chung Hwa Medical Institution
StatusCompleted
Study typeOBSERVATIONAL
Enrollment171
Start date17 September 2022
Primary completion1 April 2025
Estimated completion1 April 2025
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

Singapore Chung Hwa Medical Institution

Who can join

Adults 21 to 75, any sex, with Diabete Mellitus or Pre-diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment. This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic. A total of 250 subjects with 50 allocated in each group will be recruited to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-65 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included. Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p\<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Objective Analysis of Traditional Chinese Medicine Syndrome Differentiation of Patients With Diabetes and Prediabetes: Protocol for a Nonrandomized, Exploratory, Observational Case-Control Study Using Digitalized Traditional Chinese Medicine Diagnostic Tools.
    Ng HP, Chong SY, Li YH, Goh TH, et al · · 2024 · cited 2× · PMID 39265161 · DOI 10.2196/56024

Verify or expand the search:

Other recruiting trials for Diabete Mellitus

Currently open trials in the same condition.

Other Singapore Chung Hwa Medical Institution trials

Trials by the same sponsor.

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Data sources for this page

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