NCT05663307

The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic Stroke

The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic: A Randomized, Double Blind, Placebo Parallel Controlled Clinical Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 80 patients (age \> 40 years) with acute ischemic stroke (5\<NIHSS \< 25), 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 must be added slowly into 0.9% sodium chloride injection diluted to 250 ml , intravenous drip for about 2 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.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.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.

Conditions

• Ischemic Stroke, Acute

Interventions

Type	Name	Description
DRUG	Ginkgo diterpene lactone meglumine injection	Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
DRUG	Ginkgo diterpene lactone meglumine injection simulation	Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
DRUG	Aspirin	plus aspirin at a dose of 100 mg per day for 90 days.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2022-12-23
• Last updated: 2022-12-29

Locations

1 site across 1 country: China