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

Reza Bavarsad shahripour; Ahmad Hemati; Ana Hosseinzadeh maleki

doi:10.1007/s11655-014-1687-8

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

OriginalPaper | Updated：2021-08-27

- A Randomized trial to assess the long-term safety of NeuroAiD among Caucasian patients with acute ischemic stroke
- A Randomized trial to assess the long-term safety of NeuroAiD among Caucasian patients with acute ischemic stroke
- 中国结合医学杂志（英文版） 2014年20卷第11期页码：812-817
- Affiliations：
  
  1. Department of Neurology, Ahvaz University of Medical Sciences, Ahvaz, Khuzestan,Iran
  2. Comprehensive Stroke Center, Department of Neurology, University of Alabama at Birmingham,Birmingham,USA
- Author bio：
- Funds：
  
  Supported by funds from the Joundishapour Medical University
- DOI：10.1007/s11655-014-1687-8
  中图分类号：
- 纸质出版日期：2014，
  
  网络出版日期：2014-4-2，
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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

Reza Bavarsad shahripour, Ahmad Hemati, Ana Hosseinzadeh maleki. A Randomized trial to assess the long-term safety of NeuroAiD among Caucasian patients with acute ischemic stroke[J]. Chinese Journal of Integrative Medicine, 2014,20(11):812-817.
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 DOI：

Reza Bavarsad shahripour, Ahmad Hemati, Ana Hosseinzadeh maleki. A Randomized trial to assess the long-term safety of NeuroAiD among Caucasian patients with acute ischemic stroke[J]. Chinese Journal of Integrative Medicine, 2014,20(11):812-817. DOI： 10.1007/s11655-014-1687-8.

摘要

To assess the long-term (up to 6 months) safety profile of a 3-month regimen of NeuroAiD for acute ischemic stroke. 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. 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. NeuroAiD is safe and does not affect hematologic

hepatic

and renal functions during and long after completion of treatment.

Abstract

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

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. NeuroAiD is safe and does not affect hematologic

hepatic

and renal functions during and long after completion of treatment.

关键词

strokeNeuroAidsafety

Keywords

strokeNeuroAidsafety

references

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.

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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.

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.

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.

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.

Siow CHC. Neuroaid in stroke recovery. Eur Neurol 2008;60:264–266.

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.

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.

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.

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.

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