MedTrace Logo

Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke

NCT02149875 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-08-24

Study results available
· View outcomes & findings →

Summary

The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.

Conditions

  • Acute Cerebral Stroke Within 12 Hours for the First Time

Interventions

DRUG

Dl-3-n-butylphthalide

Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.

DRUG

Cerebrolysin

Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.

DRUG

Placebo

100 ml saline intravenous infusion once daily for 10 days.

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    lead OTHER

Principal Investigators

  • Lixia Xue, M.D., Ph.D. · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149875 on ClinicalTrials.gov