Skip to main content
OpenTrials
Completed

NCT Number: NCT02526225

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ginkgo diterpene lactone meglumine injection

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

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.

Primary outcomes

  1. Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .

    Time frame: 90 days

Secondary outcomes

  1. 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

  2. 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,

  3. Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .

    Time frame: 90 days

  4. The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.

    Time frame: Baseline,14 days,90 days

  5. The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.

    Time frame: Baseline,14 days,90 days

  6. The all-cause mortality

    Time frame: 90 days

  7. Ischemic stroke recurrence rate

    Time frame: 90 days

  8. Composite incidence of vascular events

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Bionovo Medicine Development Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 18, 2015
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.