Acute cerebral infarction
Conditions
Interventions
Experimental Group (Acute Phase):On the basis of routine Western medicine treatment, the experimental group was administered Shenqi Suxin granules (2 packets daily).
Control group (acute phase):On the basis of conventional Western medical treatment, equivalent dosage of simulated placebo is administered.
Experimental group (stable phase):In the basis of conventional Western medical treatment, the experimental group additionally used Xinyue capsules (oral administration, 2 capsules per dose, three time
Control group (stable phase):Conventional Western medical treatment plus equivalent simulated placebo
Sponsors
Beijing University of Chinese Medicine Oriental Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Patients with first-ever acute ischemic stroke, with stroke etiology (TOAST classification) being either large artery atherosclerotic type or small artery occlusion type; (2) Patients with a traditional Chinese medicine diagnosis consistent with Qi deficiency, blood stasis, and toxin syndrome; (3) Time since onset =72 hours; (4) mRS score =2 points prior to the onset of stroke symptoms; (5) NIHSS score, with a score between 3 and 25 inclusive; (6) Age between 40 and 85 years, with no restriction on gender; (7) Patients who have not undergone intravenous or intra-arterial thrombolysis or endovascular intervention; (8) Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Exclude all types of hemorrhagic cerebrovascular diseases (including subarachnoid hemorrhage, intracerebral hemorrhage, etc.) as well as transient ischemic attack (TIA) and asymptomatic cerebral infarction; (2) Cardiogenic embolism: cardiac structural abnormalities (patent foramen ovale, ventricular aneurysm), arrhythmias (atrial fibrillation, sick sinus syndrome), and intracardiac lesions (myxoma, infective endocarditis); (3) Patients with severe hepatic and renal dysfunction, malignant tumors, hematological disorders, autoimmune diseases, or severe mental disorders; (4) Pregnant and breastfeeding women; (5) Patients who have undergone intravenous thrombolysis, endovascular mechanical thrombectomy, arterial thrombolysis, or endovascular stent placement for revascularization therapy; (6) Patients allergic to or intolerant of the investigational drug; (7) Patients who have participated in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardio-cerebral composite endpoint; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurological functional recovery and activities of daily living (ADL) assessment indicators: National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Barthel Index (BI).;Imaging metrics: ASPECTS score based on non-contrast CT and cranial MRI (T1, T2, DWI, Flair sequences), CT angiography (CTA), and imaging techniques based on CT perfusion (CTP) including cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to peak (TTP).;Echocardiography: Measurements of left ventricular ejection fraction (LVEF), early rapid filling peak E wave/late filling A wave (E/A) during diastole, interventricular septum diastolic thickness (IVSD), left ventricular posterior wall diastolic thickness (LVPWD), mitral valve E wave velocity/mitral annulus e' velocity (E/E'), stroke volume (SV), cardiac output (CO), and cardiac index (CI) were obtained for both groups of patients.;Myocardial injury: biomarkers of myocardial injury (cTnI, CK-MB);Traditional Chinese Medicine (TCM) syndrome scoring (qi deficiency with blood stasis and toxicity syndrome, qi deficiency with blood stasis syndrome);Mechanism indicators (monocyte subset distribution, Th17/Treg ratio, specific cytokine levels, systemic inflammation levels); | — |
Countries
China
Contacts
Public ContactGesheng Wang
Beijing University of Chinese Medicine Oriental Hospital
Outcome results
None listed