title: 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).
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Tan Tock Seng Hospital Rehabilitation Centre, Ang Mo Kio Hospital, National University Hospital of Singapore, Singapore. keng_he_Kong @ ttsh.com.sg
authors.forename: Keng He
authors.initials: KH
authors.lastname: Kong
authors.forename: Seng Kwee
authors.initials: SK
authors.lastname: Wee
authors.forename: Chwee Yin
authors.initials: CY
authors.lastname: Ng
authors.forename: Karen
authors.initials: K
authors.lastname: Chua
authors.forename: Kay Fei
authors.initials: KF
authors.lastname: Chan
authors.forename: N
authors.initials: N
authors.lastname: Venketasubramanian
authors.forename: Christopher
authors.initials: C
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018697:Nootropic Agents / Q000627:therapeutic use*; D010865:Pilot Projects; D028321:Plant Preparations / Q000627:therapeutic use*; D020127:Recovery of Function; D012307:Risk Factors; D018401:Sample Size; D020521:Stroke / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C546417:Neuroaid; D018697:Nootropic Agents; D028321:Plant Preparations