Condition or disease | Intervention/treatment |
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Acute Ischemic Stroke Abnormal Glucose Metabolism | Drug: Urinary Kallidinogenase |
Study Type : | Observational |
Actual Enrollment : | 113 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Group/Cohort | Intervention/treatment |
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HUK group
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.
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Drug: Urinary Kallidinogenase
Other Name: Kai Li Kang
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control group
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.
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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%.
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.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion criteria:
Principal Investigator: | Xiaopeng Wang, MD | The Second Hospital of Hebei Medical University |
Tracking Information | ||||
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First Submitted Date | July 2, 2019 | |||
First Posted Date | July 16, 2019 | |||
Last Update Posted Date | July 16, 2019 | |||
Actual Study Start Date | December 2016 | |||
Actual Primary Completion Date | October 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism | |||
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 | |||
Brief Summary | Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired fasting glucose. | |||
Detailed Description | Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into two groups. The HUK group were treated with urinary kallidinogenase and standard treatment, the control group received standard treatment. NIHSS scores, mRS scores and fasting blood glucose were evaluated and compared. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients with AIS combined with diabetes mellitus and impaired fasting glucose who was meets the Inclusion and Exclusion Criteria were enrolled in this prospective cohort study and divided into two groups. | |||
Condition |
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Intervention | Drug: Urinary Kallidinogenase
Other Name: Kai Li Kang
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
113 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | October 2017 | |||
Actual Primary Completion Date | October 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria |
Inclusion Criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT04020666 | |||
Other Study ID Numbers | 2016261 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | The Second Hospital of Hebei Medical University | |||
Study Sponsor | The Second Hospital of Hebei Medical University | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | The Second Hospital of Hebei Medical University | |||
Verification Date | December 2016 |