MedTrace Logo

For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.

NCT05068349 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-09

No results posted yet for this study

Summary

This is a prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. Correlation with its efficacy and adverse reactions.

Conditions

Interventions

DRUG

Butylphthalide

Butylphthalide sodium chloride injection 25mg, 2 times a day, 7-14 days, followed by 0.2g butylphthalide soft capsules, 3 times a day, 76-83 days, a total of 90 days.

Sponsors & Collaborators

  • Qianfoshan Hospital

    lead OTHER

Principal Investigators

  • Xin Huang · Qianfoshan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-07
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05068349 on ClinicalTrials.gov