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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336153
• Other study ID #: RN89-01-117-7548
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2011
• Last updated: April 29, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 72 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• MLC601
group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month
• Placebo
group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University	hahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate the Safety and Efficacy of MLC601	Patients showed a good tolerability to treatment and adverse events were mild and transient.	18 months	Yes
Secondary	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	18 months	Yes