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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6,300
25mg, intravenous drip, once a day. Number of Cycles: 14 days.
Adverse Events
Time frame: 14 days
vital signs after 10 minutes of stasis.
Time frame: 0,14 days
Blood routine tests
Time frame: 0, 14 days
ECG
Time frame: 0, 14 days
Patient- reported outcomes,PRO
Time frame: 0, 14 days
liver function tests
Time frame: 0, 14 days
kidney function tests
Time frame: 0, 14 days
urine routine tests
Time frame: 0, 14 days
stool routine +occult blood tests
Time frame: 0, 14 days
Coagulation function tests
Time frame: 0, 14 days
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