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

Shahid Beheshti University

Status and phase

Completed

Phase 4

Conditions

Stroke

Treatments

Drug: Placebo

Drug: MLC601

Study type

Interventional

Funder types

Other

Identifiers

NCT01336153

RN89-01-117-7548

Details and patient eligibility

About

To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.

Full 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.

Enrollment

150 patients

Sex

All

Ages

30 to 72 years old

Volunteers

No Healthy Volunteers

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.