Type 2 Diabetes
Conditions
Interventions
Experimental Group:routine treatment + Yi Qi Hua Ju Tong Luo Granules
Control Group:Routine treatment + placebo granules
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent and be able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete this trial; 2. Age between 60-75 years old (including both ends), gender; 3. Meet the Western diagnostic criteria for Type 2 diabetes mellitus; 4.; 5. Metformin =1000 mg/day, with a stable dose for at least 8 weeks; 6. HbA1c 7-10.0%.
Exclusion criteria
Exclusion criteria: 1. Patients with other special types of diabetes (monogenic diabetes, drug-induced diabetes, endocrine diabetes); 2. Patients with acute complications of diabetes; 3. Patients with severe cardiovascular, cerebrovascular diseases, or severe primary diseases of the liver, kidneys, or hematopoietic system; 4. Patients with known allergies to the components of the investigational drug or with an allergic constitution; 5. Patients with long-term alcohol abuse, drug dependence, or mental illness; 6. Patients who meet any of the following laboratory criteria at screening: 6.1. ALT and AST levels more than 3 times the upper limit of normal; 6.2. Hemoglobin = 100 g/L; 6.3. Patients with renal impairment, defined as an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73 m² (using the CKD-EPI formula); 6.4. Fasting triglycerides = 5.64 mmol/L (500 mg/dl); 7. Patients who have received Chinese herbal medicine or traditional Chinese medicine for the purpose of lowering blood sugar within 8 weeks prior to screening; 8. Patients who have participated in or are currently participating in other drug clinical trials within 12 weeks of the screening period for this study; 9. Patients deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial Function Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;2-hour postprandial blood glucose;Fasting Insulin Level;glycated hemoglobin;High-sensitivity C-reactive protein;Doppler of extremity vessels;2-hour postprandial insulin; | — |
Countries
China
Contacts
Public ContactYao Zheng
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Outcome results
None listed