To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.
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.
- 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.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|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|