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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01336153
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.
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by:
Shahid Beheshti University
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 72 Years   (Adult, Senior)
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.
  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:
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