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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.
The study process lasts for a total of 90 days, including the screening period, treatment period, and follow-up period. During the treatment period, the experimental group is treated with HUK in the 48 hours of AIS plus routine clinical treatment, while the control group receives routine clinical treatment group for 7 days.All patients are followed up until the 90th day after stroke. The sample size of the study is 200 patients. The ratio of the experimental group to the control group was 1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Urinary Kallidinogenase for injection (HUK) | Experimental | 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 |
|
| sham-HUK treatment | Placebo Comparator | Normal sodium chloride injection plus routine clinical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human urinary kininogenase(HUK) | Drug | Experimental group (HUK plus routine clinical treatment): administered within 48 hours of AIS onset, 0.15PNA unit was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. |
| Measure | Description | Time Frame |
|---|---|---|
| The Favorable Stroke Outcome of 90 days | mRS 0-2 | 90 days after treatment |
| The changes of the serum inflammatory markers before and after treatment | Complete Blood Count、CRP、IL-6、HCY、NSE | Baseline、1 day after treatment、3 days after treatment、90 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of NIHSS before and after treatment | National Institute of Health stroke scale, NIHSS | Baseline、7 days after treatment |
| Stroke recurrence rate | Ischemic stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongling Zhang | Contact | +8613503615988 | zhang777hyd@163.com | |
| shanshan yang | Contact | +8613845104003 | yangshanshan81@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhongling Zhang | First Affiliated Hospital, Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongling Zhang | Recruiting | Harbin | Heilongjiang | 150001 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D009473 | Neuronal Plasticity |
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|
| Placebo | Other | Placebo group (Normal sodium chloride injection plus routine clinical treatment): Normal sodium chloride administered within 48 hours of AIS onset, by intravenous infusion for not less than 50 minutes, once a day. |
|
|
| 90 days after treatment |
| The incidence of intracranial hemorrhage | Symptomatic intracranial hemorrhage | 90 days after treatment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009424 |
| Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |