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

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: MLC601

• Registration Number: NCT01336153
• Lead Sponsor: Shahid Beheshti University

Brief 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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-01
• Status Verified: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• age between 30-72 yars,
• < one month after stroke,
• ischemic cerebral stroke,
• signed informed consent form.

Exclusion Criteria

• treatment with thrombolytic after stoke,
• ischemic stroke combined with hemorrhage, severe renal or liver failure, dementia, psychosis and history of seizure disorder, history of previous stroke, and hemoglobin level less than 10mg/dl on admission.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
MLC601	MLC601	MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components.

Primary Outcome Measures

Name	Time	Method
Investigate the Safety and Efficacy of MLC601	18 months	Patients showed a good tolerability to treatment and adverse events were mild and transient.

Secondary Outcome Measures

Name	Time	Method
Motor recovery of MLC601 in 150 Iranian Patients after Stroke	18 months	Repeated measured analysis showed statistically difference in Fugl-Meyer Assessment FMA score during 12 months between two groups