Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism
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|ClinicalTrials.gov Identifier: NCT04020666|
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment|
|Acute Ischemic Stroke Abnormal Glucose Metabolism||Drug: Urinary Kallidinogenase|
|Study Type :||Observational|
|Actual Enrollment :||113 participants|
|Official Title:||Effects of Urinary Kallidinogenase on NIHSS Score, mRS Score, and Fasting Glucose Levels in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism: a Prospective Cohort Study|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
On the basis of routine treatment for cerebral infarction, patients in the HUK group were also given Urinary Kallidinogenase at 0.15 PNA unit/day, for a 10-day course.
Drug: Urinary Kallidinogenase
Other Name: Kai Li Kang
The control group were given routine treatment for cerebral infarction, including anti-platelet aggregation, anticoagulation, lipid-lowering and plaque stabilizing, free radical scavenging, nerve nutrition and brain protection.
- NIHSS Score at 90 Days [ Time Frame: at 90 days after admission ]Comparison of NIHSS score between the control and HUK group at 90 days
- NIHSS Score at 10 Days、30 Days [ Time Frame: at 10 days, 30 days after admission ]Comparison of NIHSS score between the control and HUK group at 10days、30days.
- Factors related to Non-General Recovery (90-day NIHSS was reduced by <90%) [ Time Frame: at 90 days after admission ]
Based on NIHSS score，multivariate analysis was performed to evaluate the factors related to non-general recovery (90-day NIHSS was reduced by <90%) for all patients.
Evaluation of NIHSS score: General recovery was when NIHSS score was reduced by 90%-100%; Non-general recovery referred to when NIHSS score was reduced by <90%.
- mRS Score [ Time Frame: 10 days, 30 days, and 90 days after admission ]
The mRS score of 10 days after admission was taken as the baseline.Comparison of mRS score between the control and HUK group at 30days、90days.
Based on mRS，multivariate analysis was also performed to evaluate the factors related to poor curative effect (90-day mRS ≥3) for all patients.
Evaluation of mRS score: mRS score of 0-2 points referred to a good curative effect, and 3-5 points referred to a poor curative effect.
- fasting glucose levels [ Time Frame: at admission and 10 days after admission ]Comparison of the change in fasting glucose levels between the control and HUK group at admission and 10days.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020666
|Principal Investigator:||Xiaopeng Wang, MD||The Second Hospital of Hebei Medical University|