Back to resultsA Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ginkgo diterpene lactone meglumine injection
Ginkgo diterpene lactone meglumine injection simulation
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring acute ischemic stroke, safety and effectiveness, Ginkgo diterpene lactone meglumine injection
Eligibility Criteria
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.
Sites / Locations
- Tiantan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ginkgo diterpene lactone meglumine injection
Ginkgo diterpene lactone meglumine injection simulation
Arm Description
ginkgo diterpene lactone meglumine injection
Ginkgo diterpene lactone meglumine injection simulation
Outcomes
Primary Outcome Measures
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .
Secondary Outcome Measures
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.
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.
Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .
The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.
The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.
The all-cause mortality
Ischemic stroke recurrence rate
Composite incidence of vascular events
Full Information
NCT ID
NCT02526225
First Posted
August 5, 2015
Last Updated
March 28, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02526225
Brief Title
A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.
Official Title
A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (undefined)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
acute ischemic stroke, safety and effectiveness, Ginkgo diterpene lactone meglumine injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ginkgo diterpene lactone meglumine injection
Arm Type
Active Comparator
Arm Description
ginkgo diterpene lactone meglumine injection
Arm Title
Ginkgo diterpene lactone meglumine injection simulation
Arm Type
Placebo Comparator
Arm Description
Ginkgo diterpene lactone meglumine injection simulation
Intervention Type
Drug
Intervention Name(s)
Ginkgo diterpene lactone meglumine injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ginkgo diterpene lactone meglumine injection simulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
Baseline, 7days
Title
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.
Time Frame
Baseline,7 days,14 days,
Title
Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .
Time Frame
90 days
Title
The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.
Time Frame
Baseline,14 days,90 days
Title
The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.
Time Frame
Baseline,14 days,90 days
Title
The all-cause mortality
Time Frame
90 days
Title
Ischemic stroke recurrence rate
Time Frame
90 days
Title
Composite incidence of vascular events
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yongjun wang, M.D.
Organizational Affiliation
Beijing Tiantan Hospital,Capital Medical University,Bgeijing,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
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A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.
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