Double-blind, placebo-controlled, clinical study to investigate t | 34358
Journal of Pharmaceutical Care & Health Systems

Journal of Pharmaceutical Care & Health Systems
Open Access

ISSN: 2376-0419

Double-blind, placebo-controlled, clinical study to investigate the safety and efficacy of MLC 601 in patients after stroke

8th Annual Pharma Middle East Congress

October 10-12, 2016 Dubai, UAE

Hossein Pakdaman

Shahid Beheshti University of Medical Sciences, Iran

Posters & Accepted Abstracts: J Pharma Care Health Sys

Abstract :

Stroke is the leading cause of severe neurological disability and results in enormous cost measured in health care and lost productivity. To date, no effective treatment has been found for reducing stroke-induced disability. MLC 601 (NeuroAid) as a Traditional Chinese Medicine has been developed to aid post-stroke recovery. This is a double-blind, placebo-controlled clinical trial study on 150 patients with a recent (less than 3 month) ischemic stroke. All patients were given either MLC 601 (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. Baseline characteristics for gender, age and elapsed time from stroke onset and risk factors were not significantly different between two groups (p>0.05). There were no difference in Fugl-Meyer Assessment (FMA) score at baseline; 53.69�?±23.01 in the MLC 601 and 54.96�?±24.27 in the control group, p=0.755. FMA scores increases significantly in MLC 601 comparing to controls in 4th week (77.13�?±19.22 vs. 63.50�?±24.21; p<0.001), 8th week (82.51�?±14.27 vs. 72.06�?±21.41; p=0.001) and 12th week (86.22�?±12.34 vs. 82.78�?±14.93; p<0.001) after medication. Repeated measured analysis showed statistically difference in FMA during 12 months between two groups (p<0.001). Patients showed a good tolerability to treatment and adverse events were mild and transient. MLC 601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medication. It was more effective in motor recovery in subjects with severe and moderate than mild patients. However, still more clinical trials are needed to evaluate safety and efficacy of MLC 601 for stroke recovery.

Biography :