A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke.

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the safety of Ginkgolides Meglumine Injection in the treatment of ischemic stroke with Syndrome of Intermingled Phlegm and Blood Stasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
• Collaborator: Beijing Bionovo Medicine Development Co., Ltd.

Criteria

Inclusion Criteria:

• patients according to diagnostic standards on western medical ischemic stroke;

• patients according to diagnostic standards on Chinese medical attack to meridians;

• patients according to differentiation standards on syndrome of intermingled phlegm and blood stasis;

• 2 weeks to 6 months after attack;

• Age between 18-80 years;

• patients must volunteer to participate in this study and sign the informed consent form.

Exclusion Criteria:

• patients accompanying unconsciousness or severe dementia;

• ALT, AST≥2 times of upper limit of normal;

• patients with other severe diseases such as disease in circulatory system, hematopoietic system, digestive system, endocrine system etc;

• patients allergic to Ginkgo biloba drugs，Meglumine and meglumine agents;

• patients who are pregnant, lactating or planning for pregnancy;

• patients with insanity;

• patients who are not suitable for clinical trial under doctors' consideration;

• patients with Merge bleeding after infarction or patients with hemorrhagic tendency;

• patients with lower extremity venous thrombosis;

• patients who have participated in other clinical trial within 1 month.