Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
|ClinicalTrials.gov Identifier: NCT02149875|
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : May 18, 2016
Last Update Posted : June 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Cerebral Stroke Within 12 Hours for the First Time||Drug: Dl-3-n-butylphthalide Drug: Cerebrolysin Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
Other Name: CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
Other Name: Ever Pharma, Unterach am Attersee, Austria
Placebo Comparator: Placebo
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
100 ml saline intravenous infusion once daily for 10 days.
Other Name: Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China
- National Institutes of Health Stroke Scale Score [ Time Frame: At 11-day and 21-day after therapy ]Scores range from 0 to 42, with higher scores indicating increasing severity
- Barthel Index Score [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149875
|Shanghai Sixth People's Hospital|
|Principal Investigator:||Hao Chen, Doctor||Shanghai 6th People's Hospital|