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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MLC601
Placebo
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Safety, Efficacy, MLC601, motor recovery

Eligibility Criteria

30 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MLC601

    Placebo

    Arm Description

    MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components.

    Outcomes

    Primary Outcome Measures

    Investigate the Safety and Efficacy of MLC601
    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
    Repeated measured analysis showed statistically difference in Fugl-Meyer Assessment FMA score during 12 months between two groups

    Full Information

    First Posted
    April 13, 2011
    Last Updated
    April 29, 2011
    Sponsor
    Shahid Beheshti University
    Collaborators
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01336153
    Brief Title
    Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shahid Beheshti University
    Collaborators
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Safety, Efficacy, MLC601, motor recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MLC601
    Arm Type
    Experimental
    Arm Description
    MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MLC601
    Intervention Description
    group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months
    Primary Outcome Measure Information:
    Title
    Investigate the Safety and Efficacy of MLC601
    Description
    Patients showed a good tolerability to treatment and adverse events were mild and transient.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Motor recovery of MLC601 in 150 Iranian Patients after Stroke
    Description
    Repeated measured analysis showed statistically difference in Fugl-Meyer Assessment FMA score during 12 months between two groups
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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