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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter Safety Clinical Trial of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke With Syndrome of Intermingled Phlegm and Blood Stasis.

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Ginkgolides Meglumine Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginkgolides Meglumine Injection<br>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. | Drug: Ginkgolides Meglumine Injection<br>* 25mg, intravenous drip, once a day. Number of Cycles: 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs after 10 minutes of stasis. |  | 0，14 days | 
| Blood routine tests |  | 0, 14 days | 
| ECG |  | 0, 14 days | 
| Patient- reported outcomes,PRO |  | 0, 14 days | 
| liver function tests |  | 0, 14 days | 
| kidney function tests |  | 0, 14 days | 
| urine routine tests |  | 0, 14 days | 
| stool routine +occult blood tests |  | 0, 14 days | 
| Coagulation function tests |  | 0, 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, safety, Ginkgolides Meglumine Injection