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

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ClinicalTrials.gov Identifier: NCT01336153
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : May 2, 2011
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Stroke Drug: MLC601 Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: MLC601
MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components.
Drug: MLC601
group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Mostafa Ghanei, Ministry of Health
ClinicalTrials.gov Identifier: NCT01336153     History of Changes
Other Study ID Numbers: RN89-01-117-7548
First Posted: April 15, 2011    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: December 2010

Keywords provided by Shahid Beheshti University:
Safety
Efficacy
MLC601
motor recovery

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases