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
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, see Learn About Clinical Studies.

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 August 28, 2014