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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Collaborator: Handan Central Hospital

Criteria

Inclusion Criteria:

1. meeting the diagnostic criteria for acute ischemic stroke;

2. Patients with complete anterior circulation infarction (TACI), partial anterior circulation infarction (PACI), lacunar infarction (LACI) in OCSP classification;

3. Patients within 72 hours after onset;

4. NIHSS score ≥4 points and ≤17 points;

5. The modified Rankin Scale (MRS) score was between 0 and 1, and the MRS score before inclusion was > 2;

6. Aged between 40 and 80 (including 40 and 80); 7) Signing the Informed Consent.

Exclusion Criteria:

1. intracranial hemorrhagic disease indicated by head CT or MRI, or disease with bleeding tendency;

2. Patients treated with vascular opening (such as thrombolysis, arterial thrombectomy, ultra-early thrombosis aspiration and stenting, etc.) after the onset of this disease;

3. Cerebral embolism caused by brain tumor, brain injury, brain parasitic disease, metabolic disorder, rheumatic heart disease and coronary heart disease confirmed by examination;

4. Patients with other diseases affecting limb mobility, such as claudication, osteoarthritis (active stage), rheumatoid arthritis (active stage), gouty arthritis and other limb mobility disorders that may affect neurological function examination;

5. Patients with post-treatment systolic blood pressure ≥180 mmHg or fasting blood glucose concentration < 2.8mmol/L;

6. patients with severe heart and lung diseases and chronic liver and kidney dysfunction, including 1.5 times of the upper normal limit of liver function ALT and AST > and 1.2 times of the upper normal limit of renal function serum creatinine (SCR) >);

7. patients with complicated mental illness who are unable or unwilling to cooperate;

8. People with known allergies to the drug and its components (including excipients such as ethanol) and allergic constitution;

9. Any other patients considered by the investigator to be unsuitable for inclusion or to be affected by factors affecting study participation or completion;

10. Patients enrolled in other clinical trials within 1 month.