NCT05563090Completed
Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Patients in Singapore Using Digitalized TCM Diagnostic Tools: an Observational Study
Source: ClinicalTrials.gov · Last updated 4 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 171 (actual)
- First submitted
- 25 Sept 2022
- Start date
- 17 Sept 2022
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- Singapore Chung Hwa Medical Institution
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT05563090
What you commit to
- Study type: Observational
- Participants enrolled: 171
- From 17 Sept 2022 to the primary completion date, 1 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects diagnosed with Gestational Diabetes
- Subjects with chronic heart failure, history of carcinomas with treatment of chemotherapy/radiotherapy, psychological, or psychiatric disorders
- Subjects with heart diseases and transplanted devices such as pacemakers;
- Subjects with acute infections such as upper respiratory infections, acute gastroenteritis, or urinary tract infections;
- Subjects with communication disorders
- Subjects with gastroenterology diseases or are diagnosed with 'spleen and stomach deficiency' (脾胃虚弱)
- Subjects undergoing TCM treatment for diabetes or pre-diabetes within 1 week
Other
- Subjects who are pregnant or lactating
- Subjects unable to undergo evaluation with the pulse sphygmograph, tongue detection or complete the questionnaire;
Who the study is looking for
- Aged 21-75 years old, inclusive;
- Clinically diagnosed with one of the following:
- Type II Diabetes Mellitus with or without hypertension and dyslipidemia
- Prediabetes with or without hypertension and dyslipidemia
- Healthy or sub-healthy subject without clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia
Age in the registry: 21 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Singapore Chung Hwa Medical Institution Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.