NCT01336153

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Shahid Beheshti University · Academic / Other
• Sex: All
• Age: 30 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

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

• Stroke

Interventions

Type	Name	Description
DRUG	MLC601	group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month
DRUG	Placebo	group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-01-01
• Completion: 2010-12-01
• First posted: 2011-04-15
• Last updated: 2011-05-02