Conditions: Acute Cerebral Stroke Within 12 Hours for the First Time
Keywords: Acute ischemic stroke Dl-3-n-butylphthalide Cerebrolysin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.

Detailed description:

Arms:
arm 1: Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days arm 2: Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days arm 3: Intravenous infusion of 100 ml saline intravenous q.d. for 10 days

Interventions: intervention 1: Dl-3-n-butylphthalide intervention 2: Cerebrolysin intervention 3: Placebo
Intervention descriptions: intervention 1: Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily. intervention 2: Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days. intervention 3: 100 ml saline intravenous infusion once daily for 10 days.

Protocol document: