Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
Phase 1
Completed
- Conditions
- Acute Cerebral Stroke Within 12 Hours for the First Time
- Interventions
- Registration Number
- NCT02149875
- Lead Sponsor
- Shanghai 6th People's Hospital
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dl-3-n-butylphthalide Dl-3-n-butylphthalide Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days Cerebrolysin Cerebrolysin Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days Placebo Placebo Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
- Primary Outcome Measures
Name Time Method National Institutes of Health Stroke Scale Score At 11-day and 21-day after therapy Scores range from 0 to 42, with higher scores indicating increasing severity
- Secondary Outcome Measures
Name Time Method Barthel Index Score At 11-day and 21-day after therapy Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence
Trial Locations
- Locations (1)
Shanghai Sixth People's Hospital
🇨🇳Shanghai, China