Study of NeuroAid In Enhancing Recovery After Stroke "TIERS"

Completed

Phase 2 Results N/A

Trial Description

TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.

Conditions

Interventions

  • NeuroAid Drug
    Other Names: Danqi Piantan Jiaonang (In China)
    Intervention Desc: Neuroaid capsules, 4 capsules, three times per day, during one month
    ARM 1: Kind: Experimental
    Label: 1
    Description: Neuroaid
  • NeuroAid matched Placebo Drug
    Intervention Desc: Neuroaid matched placebo 4 capsules three times per day during one month
    ARM 1: Kind: Experimental
    Label: 2
    Description: Neuroaid matched placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer assessment 4 weeks No
Secondary Functional Independence Measure (FIM) scale 4 weeks and 8 weeks No
Secondary Fugl-Meyer subscores 4 weeks and 8 weeks No
Secondary NIHSS and NIHSS subscores 4 weeks and 8 weeks No

Sponsors