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

This study has been completed.
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by:
Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT01336153
First received: April 13, 2011
Last updated: April 29, 2011
Last verified: December 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • Investigate the Safety and Efficacy of MLC601 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   30 Years to 72 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Mostafa Ghanei, Ministry of Health
ClinicalTrials.gov Identifier: NCT01336153     History of Changes
Other Study ID Numbers: RN89-01-117-7548
Study First Received: April 13, 2011
Last Updated: April 29, 2011
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014