Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke
To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Investigate the Safety and Efficacy of MLC601 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Patients showed a good tolerability to treatment and adverse events were mild and transient.
- Motor recovery of MLC601 in 150 Iranian Patients after Stroke [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Repeated measured analysis showed statistically difference in Fugl-Meyer Assessment FMA score during 12 months between two groups
|Study Start Date:||August 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components.
group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month
|Placebo Comparator: Placebo||
group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months
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.