[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569627":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":65,"collaborators":43,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":43,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":43,"enrollmentInfo":76,"targetDuration":43,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":51,"whyStopped":43,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"First Affiliated Hospital of Harbin Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Drug: Human urinary kininogenase(HUK)",{"label":15,"type":16,"description":17,"interventionNames":18},"sham-HUK treatment","PLACEBO_COMPARATOR","Normal sodium chloride injection plus routine clinical treatment",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Human urinary kininogenase(HUK)","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.",[9],[27],"Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","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.",[15],[33],"Normal sodium chloride injection",[35],{"name":36,"affiliation":37,"role":38},"Zhongling Zhang","First Affiliated Hospital, Harbin Medical University","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+8613503615988",null,"zhang777hyd@163.com",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"shanshan yang","+8613845104003","yangshanshan81@163.com",[50],{"facility":36,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Harbin","Heilongjiang","150001","China","CN",{"type":58,"coordinates":59},"Point",[60,61],126.65,45.75,{"lat":61,"lon":60},[64],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},{"type":38,"investigatorFullName":36,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Doctor","100569627","effect-of-human-urinary-kallidinogenase-on-inflammatory-factors-in-acute-ischemic-stroke-kif-ais-100569627",false,"NCT06696703","Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)","Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)","Inclusion Criteria:\n\n1. Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;\n2. First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）\n3. Age≥18 years, male or female;\n4. 3≤Baseline NIHSS≤25;\n5. Written informed consent obtained from the patient or legally responsible person.\n\nExclusion Criteria:\n\n1. Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；\n2. Previously allergic or intolerant to injectable HUK；\n3. Used ACEI drugs prior to medication and less than 5 half-lives of the drug (according to the specific drug instructions) or received ACEI drugs during the study period;\n4. Stent surgery after the AIS onset or planned interventional therapy;\n5. Pregnancy, lactation or planned pregnancy；\n6. Life expectancy of less than 3months or inability to complete the study for other reasons；\n7. Unwilling to be followed up or poor compliance；\n8. Current participation in other clinical research;\n9. Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).","ALL","18 Years",{"count":77,"type":78},200,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84],"Acute Ischemic Stroke",[86,87,88,89],"Acute ischemic stroke","Urinary Kallidinogen","Inflammatory factors","90 days functional outcomes","2024-11-19",{"date":92,"type":93},"2024-11-20","ACTUAL",{"date":95,"type":93},"2024-01-01",{"date":97,"type":78},"2025-12-01",{"name":5,"class":6},1]