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

Completed

Phase 4 Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Ginkgolides Meglumine Injection Drug
    Intervention Desc: 25mg, intravenous drip, once a day. Number of Cycles: 14 days.
    ARM 1: Kind: Experimental
    Label: Ginkgolides Meglumine Injection
    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.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Adverse Events 14 days Yes
Secondary vital signs after 10 minutes of stasis. 0,14 days Yes
Secondary Blood routine tests 0, 14 days Yes
Secondary ECG 0, 14 days Yes
Secondary Patient- reported outcomes,PRO 0, 14 days No
Secondary liver function tests 0, 14 days Yes
Secondary kidney function tests 0, 14 days Yes
Secondary urine routine tests 0, 14 days Yes
Secondary stool routine +occult blood tests 0, 14 days Yes
Secondary Coagulation function tests 0, 14 days Yes

Sponsors