The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship "MAISKFE"

Not yet recruiting

Phase N/A Results N/A

Trial Description

Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.

Conditions

Interventions

  • Urinary Kallidinogenase for Injection Drug
    Other Names: KLK
    Intervention Desc: Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
    ARM 1: Kind: Experimental
    Label: Treatment group
    Description: Injection of Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time.
    ARM 2: Kind: Experimental
    Label: Control group
    Description: Injection of Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time.
  • Human Urinary Kallidinogenase for Injection Drug
    Other Names: KLK
    Intervention Desc: Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
    ARM 1: Kind: Experimental
    Label: Treatment group
    Description: Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time.
    ARM 2: Kind: Experimental
    Label: Control group
    Description: Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Cerebral infarction on the National Institute of Health stroke scale(NIHSS) 14 Days No
Secondary Number of Patients With Adverse Events That Are Related to Study Drug 90 Days No
Secondary Activities of daily living on the Barthel Index 90 Days No
Secondary Patients body status on the Modified Rankin Scale 90 Days No
Secondary Cerebral infarction on the National Institute of Health stroke scale 8 Days No
Secondary Recurrence rate of acute cerebral infarction 90 Days No
Primary the decrease of National Institute of Health stroke scale(NIHSS) 14 Days No
Secondary the Barthel Index 90 Days No
Secondary the Modified Rankin Scale 90 Days No
Secondary change of the National Institute of Health stroke scale 8 Days No
Secondary the composite of ischemic vascular events 90 Days No

Sponsors