A randomized trial to assess the long-term safety of NeuroAiD among Caucasian patients with acute ischemic stroke.
OBJECTIVE
To assess the long-term (up to 6 months) safety profile of a 3-month regimen of NeuroAiD for acute ischemic stroke.


METHODS
A total of 190 patients with acute ischemic stroke were identified for eligibility in a randomized, double-blind, placebo-controlled clinical trial, of which 150 patients allocated to either receiving NeuroAiD (80 cases) or placebo (70 cases) were analyzed after dropouts due to absence of baseline data, early death, or noncompliance. Both groups received treatment for three months and followed up for another three months after the completion of the treatment. Occurrence of clinical adverse events and laboratory parameters were assessed at 1 month, 3 months (while under treatment) and 6 months (3 months after the completion of treatment). Statistical comparisons between groups were performed using chi-square test or t-test whenever appropriate.


RESULTS
The two groups had comparable baseline characteristics. Mild nausea was more commonly reported in patients taking NeuroAid compared with placebo (P=0.01), of which 9 out of 10 were observed only during the first month of treatment. However, none of the adverse events reported were considered severe or required discontinuation of the study drug. There was no significant change observed in mean arterial blood pressure, haemoglobin, renal and liver laboratory parameters during treatment with NeuroAid and up to 3 months after completion of a 3-month regimen.


CONCLUSIONS
NeuroAiD is safe and does not affect hematologic, hepatic, and renal functions during and long after completion of treatment.
Department of Neurology, Ahvaz University of Medical Sciences, Ahvaz, Khuzestan, Iran, nbavar@yahoo.com.
Reza
R
Bavarsad Shahripour
Ahmad
A
Hemati
Ana
A
Hosseinzadeh Maleki
D000368:Aged; D002545:Brain Ischemia / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010349:Patient Compliance; D010919:Placebos; D020521:Stroke / Q000628:therapy*
D010919:Placebos