A Multicenter Safety Clinical Trial of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke With Syndrome of Intermingled Phlegm and Blood Stasis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6,300
- 试验地点
- 86
- 主要终点
- Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ginkgolides Meglumine Injection
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.
干预措施: Ginkgolides Meglumine Injection (Drug)
结局指标
主要结局
Adverse Events
时间窗: 14 days
次要结局
- Blood routine tests(0, 14 days)
- stool routine +occult blood tests(0, 14 days)
- ECG(0, 14 days)
- liver function tests(0, 14 days)
- Coagulation function tests(0, 14 days)
- vital signs after 10 minutes of stasis.(0，14 days)
- urine routine tests(0, 14 days)
- Patient- reported outcomes,PRO(0, 14 days)
- kidney function tests(0, 14 days)