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)

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

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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Drugs, Chinese Herbal / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nootropic Agents / therapeutic use*
  • Pilot Projects
  • Plant Preparations / therapeutic use*
  • Recovery of Function
  • Risk Factors
  • Sample Size
  • Stroke / drug therapy*
  • Treatment Outcome
  • Young Adult

Substances

  • Drugs, Chinese Herbal
  • Neuroaid
  • Nootropic Agents
  • Plant Preparations