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Completed

NCT Number: NCT01336153

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MLC601

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Investigate the Safety and Efficacy of MLC601

    Time frame: 18 months

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

Secondary outcomes

  1. Motor recovery of MLC601 in 150 Iranian Patients after Stroke

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 15, 2011
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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