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Study on the efficacy and safety of Compound Porcine Cerebroside and Ganglioside Injection in patients with acute cerebral infarction

Study on the efficacy and safety of Compound Porcine Cerebroside and Ganglioside Injection in patients with acute cerebral infarction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096309
Enrollment
Unknown
Registered
2025-01-21
Start date
2019-04-08
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

cerebral infarction

Interventions

Group A:4ml Compound Porcine Cerebroside and Ganglioside Injection
Group B:6ml Compound Porcine Cerebroside and Ganglioside Injection
Group C:10ml Compound Porcine Cerebroside and Ganglioside Injection

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for cerebral infarction, with onset over 24 hours to within 2 weeks; 2. Confirmed by brain CT or MRI; 3. Age at onset 18-75 years, regardless of gender; 4. 3 <= NIHSS <= 16; 5. Not treated with neuroprotective drugs after this onset.

Exclusion criteria

Exclusion criteria: 1. any disability related to the central nervous system that predated the stroke; 2. with a premorbid modified Rankin Scale (mRS) score more than 2 and lived dependently. 3. previously diagnosed cerebrovascular disease; 4. confirmed intracranial occupying lesions, trauma, cerebral parasitism and various cardiogenic cerebral embolisms including atrial fibrillation; 5. ganglioside deposits; 6. patients with thrombolysis or peptic ulcer who cannot take aspirin; 7. alanine aminotransferase (ALT), aspartate aminotransferase (AST) exceeding 1.5 times the upper limit of normality; urea nitrogen (BUN) exceeding 1.2 times the upper limit of normality; 8. alcohol dependent, or drug dependent on other sedatives; 9. pregnant and breastfeeding; 10. patients with impaired consciousness.

Design outcomes

Primary

MeasureTime frame
NIHSS score;mRS score;

Secondary

MeasureTime frame
Barthel Index score;

Countries

China

Contacts

Public ContactZucai Xu

Affiliated Hospital of Zunyi Medical University

docxzc@126.com+86 133 6866 3217

Outcome results

None listed

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