Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in

Status Recruiting

Clinical Trial Summary

This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(100mg once/day D1-D14) in combination, while the other half will receive aspirin(100mg once/day D1-D14).

Clinical Trial Description

This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 70 patients with acute ischemic stroke (5<NIHSS < 24), who can be treated within 4.5 to 48 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive a Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14(the injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours), combined with Acetylsalicylic acid (Aspirin) at a dose of 100 mg/d for 90 days;2) the other group will receive the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.The primary objective is to assess the anti-platelet effects of Ginkgo Diterpene Lactone Meglumine Injection combined with Aspirin versus Aspirin alone in patients with acute ischemic stroke. The study consists of 3 visits including the day of randomization, Day 14±2days and Day 90±7days. The trial is anticipated to complete in 10 months from the first subject recruitment , with 70 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05531942
Study type	Interventional
Source	Shanghai Yueyang Integrated Medicine Hospital
Contact	Chunxiang Chen, Master of Medicine
Phone	+8618616537797
Email	768449109@qq.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	January 1, 2021
Completion date	November 1, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms