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

Jiangsu Kanion Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke

Treatments: Drug: Ginkgolides Meglumine Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01958957

201311BDY04V05

Details and patient eligibility

About

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.

Full description

Ginkgolides Meglumine Injection was jointly developed by China Pharmaceutical University and Jiangsu Kanion Pharmaceutical Co., Ltd. Its pharmacal ingredients are ginkgo lactones , ginkgo lactone B, ginkgo lactone K, etc; Excipients for meglumine, citric acid, sodium chloride. It is used to treat stroke (mild-to-moderate cerebral infarction) in recovery phlegm and Syndrome of Intermingled Phlegm and Blood Stasis.

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.

Enrollment: 6,300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6,300 participants in 1 patient group

Ginkgolides Meglumine Injection

Experimental group

Description:

Intravenous drip slowly. A 1 (25 mg), will be taken slowly into the 0.9% sodium chloride injection diluted in 250 ml before use, then slow intravenous drip, once a day. The dripping speed must be strictly controlled. For the first time when using, dripping speed should be controlled for 10 \~ 15 drops per minute. After 30 minutes treatment without discomfort, dripping speed can be appropriately increased, but no more than 30 drops per minute.

Treatment:

Drug: Ginkgolides Meglumine Injection