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A Randomized trial to assess the long-term safety of NeuroAiD among Caucasian patients with acute ischemic stroke

Chinese Journal of Integrative Medicine volume 20, pages 812–817 (2014)Cite this article

Abstract

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.

Conclusion

NeuroAiD is safe and does not affect hematologic, hepatic, and renal functions during and long after completion of treatment.

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Authors and Affiliations

  1. Department of Neurology, Ahvaz University of Medical Sciences, Ahvaz, Khuzestan, Iran

    Reza Bavarsad shahripour, Ahmad Hemati & Ana Hosseinzadeh maleki

  2. Comprehensive Stroke Center, Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA

    Reza Bavarsad shahripour

Authors
  1. Reza Bavarsad shahripour
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  2. Ahmad Hemati
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  3. Ana Hosseinzadeh maleki
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Corresponding author

Correspondence to Reza Bavarsad shahripour.

Additional information

Supported by funds from the Joundishapour Medical University

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Bavarsad shahripour, R., Hemati, A. & Hosseinzadeh maleki, A. A Randomized trial to assess the long-term safety of NeuroAiD among Caucasian patients with acute ischemic stroke. Chin. J. Integr. Med. 20, 812–817 (2014). https://doi.org/10.1007/s11655-014-1687-8

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  • DOI: https://doi.org/10.1007/s11655-014-1687-8

Keywords

  • stroke
  • NeuroAid
  • safety