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Vol. 28, No. 5, 2009
Issue release date: October 2009
Cerebrovasc Dis 2009;28:514–521

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)

Kong K.H. · Wee S.K. · Ng C.Y. · Chua K. · Chan K.F. · Venketasubramanian N. · Chen C.
aTan Tock Seng Hospital Rehabilitation Centre, Ang Mo Kio Hospital, bDivision of Neurology, and cDepartment of Pharmacology, National University Hospital of Singapore, Singapore

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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.

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