This study is a multicenter, randomized, double-blind, placebo parallel control study, aim to evaluate the efficacy and safety of human urinary kallidinogenase in the treatment of acute ischemic stroke with type 2 diabetes.
The study process lasts for a total of 90 days, including the screening period, intervention period, and follow-up period. During the intervention period, the experimental group is treated with Urinary Kallidinogenase, while the control group is treated with placebo for 10 days. Both groups receive routine clinical treatment. All patients are followed up until the 90th day after stroke. The sample size of the study is 630 patients. The ratio of the experimental group to the control group is 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
630
The 0.15 peptide nucleic acids(PNA) unit of Eurecrine for injection was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days
The 0.15 peptide nucleic acids(PNA) unit of placebo was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days.
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-2 scores at 90±7 days
Time frame: 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
The proportion of patients with modified rankin scale (mRS) 0-3 scores at 90±7 days
Time frame: 90±7 days
Distribution of modified rankin scale (mRS) at 90±7 days
Distribution of modified rankin scale (mRS) at 90±7 days
Time frame: 90±7 days
Changes of NIHSS from baseline to 10 days
Changes of NIHSS from baseline to 10 days
Time frame: from baseline to day 10
Changes of Barthel index from baseline to 90±7 days
Changes of Barthel index from baseline to 90±7 days
Time frame: from baseline to day 90±7
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Changes of mini-mental state examination (MMSE) from baseline to 90±7 days
Time frame: from baseline to day 90±7
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Changes of Montreal cognitive assessment (MoCA) from baseline to 90±7 days
Time frame: from baseline to day 90±7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.