Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.

Inclusion Criteria: 1. Age between 18 and 80 years, gender not specified; 2. Clinically diagnosed with acute ischemic stroke; 3. Stroke onset within 3 hours; 4. NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point; 5. Pre-stroke mRS score ≤1 point; 6. Participants and their representatives capable and willing to sign an informed consent form. Exclusion Criteria: 1. Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma; 2. Known severe hepatic or renal dysfunction or individuals undergoing dialysis for various reasons (severe hepatic dysfunction defined as ALT levels \>3 times the upper limit of normal or AST levels \>3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine \>3.0 mg/dl \[265.2 μmol/L\] or glomerular filtration rate \[GFR\] \<30 ml/min/1.73m²); 3. Systolic blood pressure \<90 mmHg or \>220 mmHg; 4. Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome; 5. History of drug or food allergies, including known allergies to the components of the study medication; 6. Treatment with medications containing Butylphthalide following the onset of the current stroke episode; 7. Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions; 8. Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days; 9. Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures; 10. Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days; 11. Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study; 12. Any other reason deemed by the investigator as unsuitable for participation in the study.