A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Detailed Description
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After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Official Title
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A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Ginkgo diterpene lactone meglumine injection
* Drug: Ginkgo diterpene lactone meglumine injection simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years of age, and gender not limited。 Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease); The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1); The degree of nerve function defect score (NIHSS) score 4 to 24 points, body movement component (NIHSS score paragraphs 5 and 6) total score 2 points or higher; Understand and voluntarily signed informed consent. Exclusion Criteria: Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc. The serious disturbance of consciousness (Ia NIHSS score 2 points or higher); With hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis; Serious abnormal liver and kidney function, liver function laboratory indexes of ALT > 3 ULN, renal laboratory ULN Cr > 1.5); A history of mental illness or dementia patients; Severe organ or other systemic disease, accompanied by any organ or system of malignant tumor, or ongoing anti-tumor treatment, the estimated lifetime < 3 months; Significant drug or alcohol abuse; Allergic constitution, as well as to two or more drugs or food allergies;This medicine ingredients allergy or known; Have pregnancy (check blood HCG positive screening tests, namely HCG > 5 miu/mL), during the test preparation is pregnancy or lactation in women; In the past three months in other clinical trials; Researchers do not determine poor adherence, or any other suitable for patients to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ginkgo diterpene lactone meglumine injection<br>ginkgo diterpene lactone meglumine injection | Drug: Ginkgo diterpene lactone meglumine injection<br>* 5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.<br>|
| Placebo Comparator: Ginkgo diterpene lactone meglumine injection simulation<br>Ginkgo diterpene lactone meglumine injection simulation | Drug: Ginkgo diterpene lactone meglumine injection simulation<br>* 5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 . |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with National Institutes of Health Stroke Score (NIHSS) rising 4 or more points, three points, two points, one of the subjects changes from baseline to randomized 7 days. |  | Baseline, 7days | 
| Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reducing 4 points or more changes from baseline to randomized 7 days,14 days. |  | Baseline,7 days,14 days, | 
| Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 . |  | 90 days | 
| The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days. |  | Baseline,14 days,90 days | 
| The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days. |  | Baseline,14 days,90 days | 
| The all-cause mortality |  | 90 days | 
| Ischemic stroke recurrence rate |  | 90 days | 
| Composite incidence of vascular events |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, safety and effectiveness, Ginkgo diterpene lactone meglumine injection