Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;

• First clinical onset or previous presence of cerebral infarction without severe sequelae(Premorbid mRS ≤2)

• Age≥18 years, male or female;

• 3≤Baseline NIHSS≤25;

• Written informed consent obtained from the patient or legally responsible person.

Locations
Other Locations
China
Zhongling Zhang
RECRUITING
Harbin
Contact Information
Primary
Zhongling Zhang
zhang777hyd@163.com
+8613503615988
Backup
shanshan yang
yangshanshan81@163.com
+8613845104003
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 200
Treatments
Experimental: Human Urinary Kallidinogenase for injection (HUK)
Patients in this arm will be given urinary kallidinogenase for injection,0.15 peptide nucleic acids (PNA), once a day for 7days plus routine clinical treatment
Placebo_comparator: sham-HUK treatment
Normal sodium chloride injection plus routine clinical treatment
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Harbin Medical University

This content was sourced from clinicaltrials.gov