NCT01336153

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_4 stroke

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4 stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
Last Updated

May 2, 2011

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

April 13, 2011

Last Update Submit

April 29, 2011

Conditions

Stroke

Keywords

SafetyEfficacyMLC601motor recovery

Outcome Measures

Primary Outcomes (1)

  • Investigate the Safety and Efficacy of MLC601

    Patients showed a good tolerability to treatment and adverse events were mild and transient.

    18 months

Secondary Outcomes (1)

  • Motor recovery of MLC601 in 150 Iranian Patients after Stroke

    18 months

Study Arms (2)

MLC601

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MLC601DRUG

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

MLC601
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age30 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 30-72 yars,
  • \< one month after stroke,
  • ischemic cerebral stroke,
  • signed informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 15, 2011

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Study Completion

December 1, 2010

Last Updated

May 2, 2011

Record last verified: 2010-12