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Study on the Effectiveness and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

NCT04950790 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-07-07

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-parallel-controlled multiplier designed to observe and evaluate the efficacy and safety of Shuxuening injection in the treatment of acute ischemic stroke for 10 days and continue follow-up to 90 days after the onset of the disease.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Shuxinin injection

Shuxuening injection : 5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.

DRUG

Basic treatment

Give oral aspirin enteric soluble tablets 150-300mg/d as early as possible after the onset of the disease, which can be changed to a prophylactic dose (50-325mg/d) after the acute phase. For those who cannot tolerate For those who cannot tolerate aspirin, clopidogrel can be used.

DRUG

Placebo

sterilized water for injection，5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.

Sponsors & Collaborators

  • Handan Central Hospital

    collaborator OTHER

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Xiaogang Li · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2021-12-01
Completion
2021-12-01

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 NCT04950790 on ClinicalTrials.gov