Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke

Completed

Phase 4 Results N/A

Trial Description

To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.

Detailed Description

This is a double-blind, placebo-controlled clinical trial study on 150 patients with a recent (less than 3 month) ischemic stroke. All patients will give either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard medication of post stroke for 3 months. Motor improvement will be monitored using Fugl-Meyer Assessment FMA.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months
    ARM 1: Kind: Experimental
    Label: Placebo
  • MLC601 Drug
    Intervention Desc: group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month
    ARM 1: Kind: Experimental
    Label: MLC601
    Description: MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Investigate the Safety and Efficacy of MLC601 18 months Yes
Secondary Motor recovery of MLC601 in 150 Iranian Patients after Stroke 18 months Yes

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