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The efficacy and safety of Compound Troxerutin and Poreine Cerebroside Injection in the treatment of acute ischemic stroke: a multi-center, randomized, double-blind, placebo-controlled clinical study

The efficacy and safety of Compound Troxerutin and Poreine Cerebroside Injection in the treatment of acute ischemic stroke: a multi-center, randomized, double-blind, placebo-controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039862
Enrollment
Unknown
Registered
2020-11-12
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischaemic stroke

Interventions

Experimental group:Compound Troxerutin and Poreine Cerebroside Injection, 10 ml, added to 250 ml 0.9% sodium chloride injection, intravenous drip, once a day, continuous medication for 10 days
Control group:Placebo,10 ml, added to 250 ml 0.9% sodium chloride injection, intravenous drip, once a day, continuous medication for 10 days

Sponsors

The First Affiliated Hospital of Ji'nan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnosis of acute ischemic stroke; 2) Within 72h of onset; 3) 4 points = 2 points; 4) 18 <= age <= 80 years; 5) Subjects or their guardians informed consent and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients who have received early recanalization (thrombolysis or endovascular treatment); 2) Patients with stroke caused by brain tumors, brain trauma, blood diseases, etc.; 3) Those who have a history of stroke and whose sequelae seriously affect the outcome evaluation, that is, the modified Rankin scale score >= 2 before the onset of the stroke; 4) Complicated with other diseases that affect the function of the limbs, combined with limb movement dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. before treatment, affecting the neurological function examination; 5) Patients with severe liver, kidney, and cardiac insufficiency (Note: Liver insufficiency means that the ALT or AST value is greater than 2.5 times the upper limit of normal; renal insufficiency means that the blood creatinine value is greater than 2.5 times the upper limit of normal; cardiac insufficiency means left The ventricular ejection fraction is less than 50%.); 6) It is clear that patients with ischemic stroke combined with atrial fibrillation or the pathogenesis considered as cardiogenic embolism; 7) Patients with allergies or allergic to research drugs; 8) Suffer from other serious diseases and the expected survival time is less than 3 months; 9) Large-area infarction with severe disturbance of consciousness (NIHSS scale 1a item score >= 2 points) or dementia, or other mental impairment, the researcher considers not suitable for participating in the study; 10) Patients with inherited abnormal glucose and lipid metabolism (ganglioside accumulation diseases, such as familial amaurian dementia, retinal degeneration); 11) Pregnant or breastfeeding women, mental patients; 12) Participants in other clinical trials in the past month.

Design outcomes

Primary

MeasureTime frame
NIHSS scale score;

Countries

China

Contacts

Public ContactAnding Xu, Zefeng Tan

The First Affiliated Hospital of Ji'nan University

tlil@jnu.edu.cn+86 13392692160; +86 15918749307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026