NCT02526225

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3,452 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 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

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-05-01
• Completion: 2019-08-31
• First posted: 2015-08-18
• Last updated: 2023-03-30

Locations

1 site across 1 country: China