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Effectiveness of Butylphthalide on Dynamic Cerebral Autoregulation in Patients With Acute Ischemic Stroke.

NCT03413202 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2022-06-30

No results posted yet for this study

Summary

This is a randomized, triple-blind, placebo-controlled, multicenter clinical trial. Eligible patients will be randomized into either the butylphthalide (NBP) or placebo group in a 2:1 ratio.The main purpose of this study is to determine whether butylphthalide can improve dynamic Cerebral Autoregulation (dCA) in large-artery atherosclerosis acute ischemic stroke.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

butylphthalide(NBP)

Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 25mg butylphthalide(NBP) injection, and 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, butylphthalide(NBP) capsule for 76 days.

DRUG

placebo

Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, starch capsule for 76 days.

Sponsors & Collaborators

  • Yi Yang

    lead OTHER

Principal Investigators

  • Yi Yang, MD, PhD · Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2022-03-25
Completion
2022-05-25

Countries

  • China

Study Locations

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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 NCT03413202 on ClinicalTrials.gov