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Using Shuxuening Injection to enhance treatment for ischemic stroke

Efficacy and Safety of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial

Phase 3 Interventional Beijing Tiantan Hospital · NCT06157502

This study is testing if a new injection called Shuxuening can help people recover better from an ischemic stroke when given alongside standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1380 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorBeijing Tiantan Hospital Academic / other
Locations82 sites (Beijing, Beijing Municipality and 81 other locations)
Trial IDNCT06157502 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Shuxuening injection as a neuroprotective agent in patients undergoing intravenous thrombolysis for acute ischemic stroke. A total of 1380 patients will be enrolled from 50 centers in China, all of whom must be treated within 6 hours of stroke onset. Participants will be randomly assigned to receive either the Shuxuening injection or a placebo for a duration of 10-14 days. The primary outcomes will assess functional recovery and safety through mRS scores and adverse events within 90 days.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older diagnosed with acute ischemic stroke who can receive treatment within 6 hours of onset.

Not a fit: Patients with pre-existing functional disabilities or those receiving other neuroprotective agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While the use of neuroprotective agents in stroke treatment is a common area of investigation, the specific application of Shuxuening injection in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age 18 or older;
* Diagnosed with acute ischemic stroke;
* Within 6 hours of onset;
* Having received or plan to undergo intravenous thrombolytic therapy;
* NIHISS score of 4 to 25 points at enrollment;
* Signed informed consent.

Exclusion Criteria:

* mRS score greater than 1 point before the onset;
* Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset;
* Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI;
* History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
* Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal);
* Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract);
* Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures;
* Participation in another clinical trial with an experimental product during the last 30 days;
* Other participants deemed unsuitable for participation in this study by the investigator.

Where this trial is running

Beijing, Beijing Municipality and 81 other locations

+32 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic Stroke, AcuteIschemic StrokeIntravenous ThrombolysisNeuroprotective TherapyShuxuening InjectionRandomized Controlled Trial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.