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

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. Identifier: NCT01336153
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : May 2, 2011
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

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, Older Adult)
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.

Responsible Party: Mostafa Ghanei, Ministry of Health 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:
motor recovery

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