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Cerebrovasc Dis. 2009;28(5):514-21. doi: 10.1159/000247001. Epub 2009 Oct 9.

A double-blind, placebo-controlled, randomized phase II pilot study to investigate the potential efficacy of the traditional chinese medicine Neuroaid (MLC 601) in enhancing recovery after stroke (TIERS).

Author information

  • 1Tan Tock Seng Hospital Rehabilitation Centre, Ang Mo Kio Hospital, National University Hospital of Singapore, Singapore. keng_he_Kong @ ttsh.com.sg

Abstract

BACKGROUND AND OBJECTIVE:

Previous clinical studies have shown that Neuroaid (MLC 601) may be beneficial in post-stroke rehabilitation. Our aim was to investigate the efficacy of Neuroaid on motor recovery in ischemic stroke patients using rehabilitation endpoints in accordance with the International Conference on Harmonization/Good Clinical Practice guidelines, in order to provide predictive information for further larger trials.

METHODS:

This is a phase II double-blind, placebo-controlled pilot study of 40 subjects admitted with a recent (less than 1 month) ischemic stroke. All subjects were given either Neuroaid or placebo, 4 capsules 3 times a day for 4 weeks. Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale and Functional Independence Measure scores were measured at initiation of the treatment, and at 4 and 8 weeks.

RESULTS:

None of the outcomes was statistically significant between the two groups. However, FMA scores showed a positive trend for improvement with Neuroaid treatment over time. Subgroup analysis of subjects with posterior circulation infarction and severe stroke both showed a tendency for better recovery.

CONCLUSION:

Some positive trends were observed in the Neuroaid group. A larger multicenter trial focusing on severe stroke patients is needed to better evaluate the role of Neuroaid in aiding stroke recovery in rehabilitation.

Copyright 2009 S. Karger AG, Basel.

PMID:
19816018
[PubMed - indexed for MEDLINE]
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