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

NCT ID: NCT02526225

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2019-08-31

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

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ginkgo diterpene lactone meglumine injection

ginkgo diterpene lactone meglumine injection

Group Type: ACTIVE_COMPARATOR

Ginkgo diterpene lactone meglumine injection

Intervention Type: DRUG

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.

Ginkgo diterpene lactone meglumine injection simulation

Ginkgo diterpene lactone meglumine injection simulation

Group Type: PLACEBO_COMPARATOR

Ginkgo diterpene lactone meglumine injection simulation

Intervention Type: DRUG

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.

Interventions

Ginkgo diterpene lactone meglumine injection

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

Ginkgo diterpene lactone meglumine injection simulation

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

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Bionovo Medicine Development Co., Ltd.

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

Executive Vice-President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yongjun wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital,Capital Medical University,Bgeijing,China

Locations

Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Tian X, Xu Q, Xia X, Zhang Y, Zhao X, Wang A. Effect of ginkgo diterpene lactone meglumine on the quality of life in patients with acute ischemic stroke. Health Qual Life Outcomes. 2024 Nov 15;22(1):99. doi: 10.1186/s12955-024-02315-1.

Reference Type: DERIVED

PMID: 39548582 (View on PubMed)

Zhang Q, Wang A, Xu Q, Xia X, Tian X, Zhang Y, Li X, Yang X, Wang X, Peng J, Li Y, Liu L, Jin S, Meng X, Zhao X; GDLM group. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2328828. doi: 10.1001/jamanetworkopen.2023.28828.

Reference Type: DERIVED

PMID: 37578791 (View on PubMed)

Other Identifiers

1412-Z-YXET-ZS-RE

Identifier Type: -

Identifier Source: org_study_id