Advertisement

Chinese Journal of Integrative Medicine

, Volume 20, Issue 11, pp 812–817 | Cite as

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

  • Reza Bavarsad shahripourEmail author
  • Ahmad Hemati
  • Ana Hosseinzadeh maleki
Original 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.

Keywords

stroke NeuroAid safety 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Bavarsad shahripour R, Donnan GA. The long-term management of stroke. In: Norrving B, ed. Oxford textbook of stroke and cerebrovascular disease. 1 ed. USA: Oxford University Press; 2014:243–254.CrossRefGoogle Scholar
  2. 2.
    Bavarsad shahripour R, Alexandrov AV. Ancillary approaches to plasminogen activators. Ann NY Acad Sci 2012;1268:113–119.PubMedCrossRefGoogle Scholar
  3. 3.
    Bavasard Shahripour R, Shamsaei G, Pakdaman H, Majdinasab N, Nejad EM, Sajedi SA, et al. The effect of NeuroAiD (MLC601) on cerebral blood flow velocity in subjects’ post brain infarct in the middle cerebral artery territory. Eur J Intern Med 2011;22:509–513.CrossRefGoogle Scholar
  4. 4.
    Quintard H, Borsotto M, Veyssiere J, Gandin C, Labbal F, Widman C, et al. MLC901, a traditinal Chinese medicine protects the brain against global ischemia. Neuropharmacology 2011;61:622–631.PubMedCrossRefGoogle Scholar
  5. 5.
    Heurteaux C, Gandin C, Borsotto M, Widmann C, Brau F, Lhuillier M, et al. Neuroprotective and neuroproliferative activities of NeuroAid (MLC601, MLC901), a Chinese medicine, in vitro and in vivo. Neuropharmacology 2010;58:987–1001.PubMedCrossRefGoogle Scholar
  6. 6.
    Venketasubramanian N, Chen CL, Gan RN, Chan BP, Chang HM, Tan SB, et al. A double-blind, placebocontrolled, randomized, multicentre study to investigate Chinese medicine NeuroAiD efficacy on stroke recovery (CHIMES Study). Int J Stroke 2009;4:54–60.PubMedCrossRefGoogle Scholar
  7. 7.
    Siow CHC. Neuroaid in stroke recovery. Eur Neurol 2008;60:264–266.PubMedCrossRefGoogle Scholar
  8. 8.
    Chen C, Venketasubramanian N, Gan RN, Lambert C, Picard D, Chan BPL, et al. Danqi Piantang Jiaonang (DJ), a traditional Chinese medicine, in poststroke recovery. Stroke 2009;40:859–863.PubMedCrossRefGoogle Scholar
  9. 9.
    Harandi AA, Abolfazli R, Hatemian A, Ghragozlee K, Ghaffar-Pour M, Karimi M, et al. Safety and efficacy of MLC601 in Iranian patients after stroke: a double-blind, placebo-controlled clinical trial. Stroke Res Treatment 2011;2011:721613.CrossRefGoogle Scholar
  10. 10.
    Gan R, Lambert C, Lianting J, Chan E S Y, Venketasubramanian N, Chen C, et al. Danqi Piantang Jiaonang does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients. Cerebrovasc Dis 2008;25:450–456.PubMedCrossRefGoogle Scholar
  11. 11.
    Young SHY, Zhao Y, Koh A, Singh R, Chan BPL, Chang HM, et al. Safety profile of MLC601 (NeuroAiD) in acute ischemic stroke patients: a Singaporean substudy of the Chinese medicine neuroaid efficacy on stroke recovery study. Cerebrovasc Dis 2010;30:1–6.PubMedCrossRefGoogle Scholar

Copyright information

© Chinese Association of the Integration of Traditional and Western Medicine and Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Reza Bavarsad shahripour
    • 1
    • 2
    Email author
  • Ahmad Hemati
    • 1
  • Ana Hosseinzadeh maleki
    • 1
  1. 1.Department of NeurologyAhvaz University of Medical SciencesAhvaz, KhuzestanIran
  2. 2.Comprehensive Stroke Center, Department of NeurologyUniversity of Alabama at BirminghamBirminghamUSA

Personalised recommendations