Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      At present, the treatment of acute ischemic stroke includes intravenous thrombolysis,
      intravascular interventional therapy (including arterial thrombolysis, mechanical
      thrombectomy, angioplasty and stent implantation), antiplatelet therapy, anticoagulant
      therapy, defibrasion therapy, volume expansion therapy, and neuroprotective therapy. Y-2
      sublingual tablet is an innovative drug developed by Yantai yinuoyi Biomedical Technology
      Co., Ltd. with independent intellectual property rights. This product is a free radical
      scavenger and inflammatory protein expression inhibitor. It can clear hydroxyl free radical
      (COH), nitric oxide free radical (no) and peroxynitrite ion (onoa), and inhibit the
      expression of tumor necrosis factor-A (TNF-a), interleukin IP (IL-1 (3), cyclooxygenase-2
      (COX-2) and inducible nitric oxide synthase (iNOS) and other inflammatory related proteins
      induced by cerebral ischemia. By clearing the excessive free radicals produced in the brain
      tissue during ischemia and reperfusion and inhibiting the secondary inflammatory reaction, we
      can reduce the damage of free radicals and inflammatory reaction to the brain tissue, block
      the pathological change process caused by cerebral ischemia from two ways, and play a
      synergistic therapeutic role in cerebral ischemia injury.
    

Detailed description: 
      At present, the treatment of acute ischemic stroke includes intravenous thrombolysis,
      intravascular interventional therapy (including arterial thrombolysis, mechanical
      thrombectomy, angioplasty and stent implantation), antiplatelet therapy, anticoagulant
      therapy, defibrasion therapy, volume expansion therapy, and neuroprotective therapy. Y-2
      sublingual tablet is an innovative drug developed by Yantai Yinuoyi Biomedical Technology
      Co., Ltd. with independent intellectual property rights. This product is a free radical
      scavenger and inflammatory protein expression inhibitor. It can clear hydroxyl free radical
      (COH), nitric oxide free radical (no) and peroxynitrite ion (onoa), and inhibit the
      expression of tumor necrosis factor-A (TNF-a), interleukin IP (IL-1 (3), cyclooxygenase-2
      (COX-2) and inducible nitric oxide synthase (iNOS) and other inflammatory related proteins
      induced by cerebral ischemia. By clearing the excessive free radicals produced in the brain
      tissue during ischemia and reperfusion and inhibiting the secondary inflammatory reaction, we
      can reduce the damage of free radicals and inflammatory reaction to the brain tissue, block
      the pathological change process caused by cerebral ischemia from two ways, and play a
      synergistic therapeutic role in cerebral ischemia injury.
    

Intervention name(s): Y-2 sublingual tablets; d-borneol
Intervention type(s): Drug; Drug
Intervention description(s): 30mg Edaravone+6mg d-borneo OR， Bid; 60 μg d-borneol OR， Bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment