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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01336153

Enrollment

150

Registered

2011-04-15

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Safety, Efficacy, MLC601, motor recovery

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.

Interventions

DRUGMLC601

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 72 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026