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
About this trial
This is an interventional treatment trial for Stroke focused on measuring Safety, Efficacy, MLC601, motor recovery
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.
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
NCT ID
NCT01336153
First Posted
April 13, 2011
Last Updated
April 29, 2011
Sponsor
Shahid Beheshti University
Collaborators
Shahid Beheshti University of Medical Sciences
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
We'll reach out to this number within 24 hrs