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

NCT ID: NCT01336153

Last Updated: 2011-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MLC601

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

Group Type EXPERIMENTAL

MLC601

Intervention Type DRUG

group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months

Interventions

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MLC601

group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month

Intervention Type DRUG

Placebo

group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Shahid Beheshti University

OTHER

Sponsor Role lead

Responsible Party

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Ministry of Health

Other Identifiers

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RN89-01-117-7548

Identifier Type: -

Identifier Source: org_study_id

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