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

Shahid Beheshti University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Stroke

Interventions

MLC601DRUG

group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month

PlaceboDRUG

group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months

Eligibility

Sex: ALLMin age: 30 YearsMax age: 72 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Investigate the Safety and Efficacy of MLC601

Patients showed a good tolerability to treatment and adverse events were mild and transient.

Time frame: 18 months

Secondary Outcomes

Motor recovery of MLC601 in 150 Iranian Patients after Stroke

Repeated measured analysis showed statistically difference in Fugl-Meyer Assessment FMA score during 12 months between two groups

Time frame: 18 months

Data from ClinicalTrials.gov

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