Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke
This study has been completed.
Sponsor:
Shahid Beheshti University
Collaborator:
Shaheed 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
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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 |
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 May 23, 2013