At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.
In Brief
A Phase 2 clinical trial evaluating Dl-3-n-butylphthalide, Cerebrolysin, and 1 other intervention for Acute Cerebral Stroke Within 12 Hours for the First Time. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
100 ml saline intravenous infusion once daily for 10 days.