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

Capital Medical University

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: Ginkgo diterpene lactone meglumine injection simulation; Drug: Ginkgo diterpene lactone meglumine injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02526225

1412-Z-YXET-ZS-RE

Details and patient eligibility

About

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

Full 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

Enrollment: 3,452 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 to 80 years of age, and gender not limited。
2. Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease);
3. The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
4. 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;
5. Understand and voluntarily signed informed consent.

Exclusion criteria

1. 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.
2. The serious disturbance of consciousness (Ia NIHSS score 2 points or higher);
3. With hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis;
4. Serious abnormal liver and kidney function, liver function laboratory indexes of ALT > 3 ULN, renal laboratory ULN Cr > 1.5);
5. A history of mental illness or dementia patients;
6. 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;
7. Significant drug or alcohol abuse;
8. Allergic constitution, as well as to two or more drugs or food allergies;This medicine ingredients allergy or known;
9. Have pregnancy (check blood HCG positive screening tests, namely HCG > 5 miu/mL), during the test preparation is pregnancy or lactation in women;
10. In the past three months in other clinical trials;
11. Researchers do not determine poor adherence, or any other suitable for patients to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,452 participants in 2 patient groups, including a placebo group

ginkgo diterpene lactone meglumine injection

Active Comparator group

Description:

ginkgo diterpene lactone meglumine injection

Treatment:

Drug: Ginkgo diterpene lactone meglumine injection

Ginkgo diterpene lactone meglumine injection simulation

Placebo Comparator group

Description:

Ginkgo diterpene lactone meglumine injection simulation

Treatment:

Drug: Ginkgo diterpene lactone meglumine injection simulation