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

April 29, 2011 updated by: Shahid Beheshti University
To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the Safety and Efficacy of MLC601
Time Frame: 18 months
Patients showed a good tolerability to treatment and adverse events were mild and transient.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor recovery of MLC601 in 150 Iranian Patients after Stroke
Time Frame: 18 months
Repeated measured analysis showed statistically difference in Fugl-Meyer Assessment FMA score during 12 months between two groups
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University

Collaborators

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 14, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Estimate)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 29, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN89-01-117-7548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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