Ischemic stroke with Type 2 diabetes mellitus
Conditions
Interventions
Experimental Group:Tongsemai tablets (oral, 5 tablets per dose, 3 times daily) + guideline-based standardized internal medical treatment
Control Group:Tongsemai tablet simulator (oral, 5 tablets per dose, 3 times daily) + standardized internal medical treatment based on guidelines.
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for ischemic stroke and type 2 diabetes mellitus; 2. Patients with an ischemic stroke course within 2 weeks; 3. Meet the TCM diagnostic criteria for both qi and yin deficiency syndrome (qi deficiency and yin deficiency symptom element scores are both =10 points); 4. Have =2 of the following symptoms (numbness in limbs, weakness in limbs, thalamic pain-like symptoms, shoulder-hand syndrome, autonomic nervous system symptoms, cold hands and feet); 5. NIHSS score =4 points and =20 points; 6. Age =18 years and =80 years; 7. Agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with intracranial hemorrhage, brain tumors, brain trauma, or those who have developed post-stroke hemorrhagic transformation, severe cerebral edema, increased intracranial pressure, pulmonary embolism, or epilepsy as severe complications; 2. Patients with a history of stroke, with a modified Rankin Scale (mRS) score = 2 before the current stroke episode; 3. Patients with diabetic ketoacidosis or hyperglycemic hyperosmolar state; 4. Patients with other diseases that limit neurological function assessment, such as claudication, active-phase osteoarthritis, or active-phase rheumatoid arthritis; 5. Patients with severe primary diseases of the heart, liver, kidneys, or hematological system, including heart failure, acute coronary syndrome, acute pericarditis, malignant tumors, or psychiatric disorders; 6. Patients with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), or serum creatinine (Scr) > 1.2 times ULN; 7. Patients with chronic alcohol abuse or drug abuse; 8. Pregnant or lactating women; 9. Patients allergic to the investigational drug or its components; 10. Patients who participated in other clinical studies within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Changes in Primary Symptom Assessment Scale Scores Between Ischemic Stroke Patients with Diabetes and Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of assessment scores of major symptoms in patients with ischemic stroke and diabetes on Day 30 and Day 60, as well as changes from baseline.;The proportion of mRS(modified Rankin scale) scores =1 point;The incidence rate of composite vascular events (recurrence of stroke, vascular death, new coronary artery events);Comparison of EQ-5D-5L(?EuroQol Five-Dimension Health Questionnaire with 5 Levels) Scale Scores and Baseline Differences;the proportion of Diabetic Peripheral Neuropathy (DPN) and the proportion of incident DPN;Comparison of Toronto Clinical Scoring System (TCSS) with Baseline Differences and Severity Grading Distribution; | — |
Countries
China
Contacts
Public ContactGao Ying
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed