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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 15, 2011
Last Update Posted: May 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Shahid Beheshti University of Medical Sciences
Information provided by:
Shahid Beheshti University
To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.

Condition Intervention Phase
Stroke Drug: MLC601 Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 150
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Information from the National Library of Medicine

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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Mostafa Ghanei, Ministry of Health
ClinicalTrials.gov Identifier: NCT01336153     History of Changes
Other Study ID Numbers: RN89-01-117-7548
First Submitted: April 13, 2011
First Posted: April 15, 2011
Last Update Posted: May 2, 2011
Last Verified: December 2010

Keywords provided by Shahid Beheshti University:
motor recovery

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