Acute Ischemic Stroke (AIS)
Conditions
Interventions
Treatment Group:Guideline-based conventional Western medical treatment + Shaojiao Maomei decoction (1 dose daily, taken warm in 3 divided doses: morning, midday, and evening,treatment duration: 28 day
Control group:Guideline-based conventional Western medical treatment
Sponsors
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 -80years. (2) Acute onset within 7 hours to 7 days, confirmed by MRI or CT. (3) Baseline NIHSS score 1–21. (4) Pre-stroke mRS score = 1. (5) Signed informed consent obtained from the patient or legally authorized representative.
Exclusion criteria
Exclusion criteria: (1) Any bleeding disorder on CT or MRI: hemorrhagic stroke, epidural or intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation of infarction. (2) Transient ischemic attack (TIA). (3) Severe disturbance of consciousness: NIHSS item 1a >1; or any of NIHSS items 5a, 5b, 6a, 6b scored >2. (4) Stroke clearly due to brain tumor, trauma, hematologic disease, or other identifiable cause. (5) Known bleeding diathesis. (6) Patients who underwent endovascular therapy after stroke onset. (7) Dementia, advanced Parkinson's disease, psychotic disorder, limb dysfunction from other causes, or any condition that could interfere with efficacy evaluation. (8) Uncontrolled hypertension (systolic =200 mmHg or diastolic =110 mmHg) or hypotension (systolic =90 mmHg or diastolic =60 mmHg); severe hyperglycemia (blood glucose =400 mg/dL) or hypoglycemia (blood glucose =50 mg/dL). (9) Severe hepatic impairment (transaminases >2× upper limit of normal); severe renal impairment (serum creatinine >1.5× ULN); cardiac dysfunction or other systemic disease with life expectancy =3 months. (10) Concomitant malignancy or ongoing antitumor therapy. (11) History of hypersensitivity to any study medication. (12) Pregnant, lactating, or at risk of becoming pregnant. (13) Participation in another clinical trial within the past three months or currently enrolled. (14) Any other condition that, in the opinion of the investigator, warrants exclusion from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| National Institutes of Health Stroke Scale (NIHSS) score;Barthel index ;Ischemic cerebrovascular event;Composite vascular events; | — |
Countries
China
Contacts
Public ContactZhang Lin
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Outcome results
None listed