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

March 28, 2023 updated by: Yongjun Wang, Beijing Tiantan Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3452

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ginkgo diterpene lactone meglumine injection
Drug: 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.
Placebo Comparator: Ginkgo diterpene lactone meglumine injection simulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .
Time Frame: 90 days
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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.
Time Frame: Baseline, 7days
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.
Time Frame: Baseline,7 days,14 days,
Baseline,7 days,14 days,
Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .
Time Frame: 90 days
90 days
The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.
Time Frame: Baseline,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.
Time Frame: Baseline,14 days,90 days
Baseline,14 days,90 days
The all-cause mortality
Time Frame: 90 days
90 days
Ischemic stroke recurrence rate
Time Frame: 90 days
90 days
Composite incidence of vascular events
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Bionovo Medicine Development Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1412-Z-YXET-ZS-RE

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