Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai 6th People's Hospital
• Treatments: 3-n-butylphthalide; Cerebrolysin

Criteria

Inclusion Criteria:

• Acute ischemic stroke within 12 hours for the first time before entry into the study

• National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25

Exclusion Criteria:

• with lacunar infarction

• with cerebral hemorrhagic infarction

• with epilepsy or epileptic persons

• with history of neurological diseases

• with myocardial infarction,

• with renal and hepatic abnormalities

• with metabolic diseases

• with contraindications to antiplatelet treatments