A double-blind , placebo-controlled and randomized trial of Cerebrolysin in patients with acute ischemic stroke in Iran

Stroke is the third common cause of mortality and the most common neurologic disease resulting disability in the United States. Because the disability caused by this disease and its effects on the quality of life of the patients and economic burden, is an important health problem in the societies. Various treatments proposed for this disease that one of them is cerebrolysin administration. This agent stimulates cell differentiations, has direct effect of neurons' regeneration, reduce the infarct size area, reduce the apoptosis and edema and stabilize blood circulation to involved area. The aim of this study was evaluating the therapeutic effect of cerebrolysin in patients with stroke. In a randomized controlled trialed 122 patients with confirmed ischemic acute stroke enrolled to study. The patients divided to two groups, study and control group. The study group received 10 ml cerebrolysin in 100 ml saline as an infusion for 30 minutes daily during seven days and control group received only saline same by same way of the study group. All the patients evaluated at the days 1, 3, 7 and 30 for the CSS, MRS and Barthel index for treatment results. The results analyzed by tstudent test and chi-square test with the SPSS software. The mean of Canadian Stroke Scale score (CSS) at the day 7 increased about 59% in study group and about 42% in the control group (p>0.05). There was not significant differences between two groups in terms of subgroup (CSS (GCS, tongue and physical functions) Barthel and MRS index (P>0.05)). This study indicates cerebrolysin has not noticeable effect in the patients with acute ischemic stroke.