Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
Not Applicable
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: PlaceboDrug: Chinese herbal medicine
- Registration Number
- NCT01844050
- Lead Sponsor
- Shanghai University of Traditional Chinese Medicine
- Brief Summary
Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
- After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l<2h PG<16mmol/l
- Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
- Subject is willing to participate and capable of giving informed consent.
Exclusion Criteria
- Those patients used any drugs for treatment of diabetes within one month.
- Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
- Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
- Women who were pregnant, lactating or planned pregnant.
- Allergic constitution and has a history of drug allergy.
- Combined with severe acute or chronic infections.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine. Chinese herbal medicine Chinese herbal medicine Individualized Treatment with Chinese herbal
- Primary Outcome Measures
Name Time Method Change from Baseline Total score of diabetes symptoms at 4 weeks 0 weeks(baseline), 2 weeks, 4 weeks
- Secondary Outcome Measures
Name Time Method Change from Baseline blood glucose at 2 hours after meal at 4 weeks 0 weeks(baseline), 2 weeks, 4 weeks Change from Baseline Fasting Blood Glucose at 4 weeks 0 weeks(baseline), 2 weeks, 4 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of Chinese herbal medicine in managing Type 2 Diabetes Mellitus symptoms?
How does syndrome differentiation treatment in Traditional Chinese Medicine compare to standard-of-care therapies for Type 2 Diabetes Mellitus in terms of effectiveness and safety?
Are there specific biomarkers that can predict patient response to Chinese herbal medicine in the context of Type 2 Diabetes Mellitus treatment?
What are the known or potential adverse events associated with Chinese herbal medicine used in syndrome differentiation treatment for Type 2 Diabetes Mellitus, and how can they be managed?
What related compounds or combination approaches are being explored alongside Traditional Chinese Medicine for the treatment of Type 2 Diabetes Mellitus, and how do they compare to competitor drugs in clinical trials?
Trial Locations
- Locations (1)
Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai University of Traditional Chinese Medicine🇨🇳Shanghai, Shanghai, China