CHInese Medicine NeuroAid Efficacy on Stroke Recovery "CHIMES"

Completed

Phase 3 Results N/A

Trial Description

CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity.

Detailed Description

Stroke is a major cause of death and disability. Previous clinical studies performed in China have shown that NeuroAiD increase stroke patients'recovery in terms of neurological disability and functional outcome{Chen et al,2009}and thus may be beneficial as part of a post-stroke rehabilitation programme.
In the CHIMES study,we seek to test the hypothesis that NeuroAiD is superior to a placebo in reducing neurological deficit and improving functional outcome in patients recruited within 72 h after the ischemic stroke with intermediate range of severity {6<_NIHSS<_14}.More details of the study protocol have recently been published {Venketasubramanian et al,2009}.

Conditions

Interventions

  • NeuroAid Drug
    Other Names: Danqi Piantan Jiaonang (In China)
    Intervention Desc: 4 capsules 3 times daily, for three months
    ARM 1: Kind: Experimental
    Label: A
    Description: NeuroAid
  • NeuroAid matched Placebo Drug
    Intervention Desc: NeuroAid matched Placebo, 4 capsules 3 times daily, for three months
    ARM 1: Kind: Experimental
    Label: B
    Description: NeuroAid matched Placebo

Trial Design

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

Patient Involvement

Patients will have baseline mRS, NISS, Barthel Index, and MMSE. All will be repeated at 3 months. Patients will take either NeuroAid or placebo 4 capsules 3 times daily for three months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale (mRS) at 3 months.
Secondary NISS, Barthel Index, MMSE at 3 months.
Primary Distribution modified Rankin Scale grades for all randomized subjects 3 months No
Secondary NIHSS, Barthel Index, MMSE 3 months Yes

Sponsors