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

Phase 4

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Ginkgolides Meglumine Injection

• Registration Number: NCT01958957
• Lead Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd

Brief Summary

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.

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-06
• Study First Submitted: 2013-09-29
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ginkgolides Meglumine Injection	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events	14 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (86)

CN027; 🇨🇳 Baotou, China

CN043; 🇨🇳 Changchun, China

CN051; 🇨🇳 Anyang, China

CN026; 🇨🇳 Huhehaote, China

CN073; 🇨🇳 Baoding, China

CN001; 🇨🇳 Beijing, China

CN059; 🇨🇳 Ha'erbin, China

CN078; 🇨🇳 Handan, China

CN054; 🇨🇳 Baotou, China

CN080; 🇨🇳 Cangzhou, China

CN007; 🇨🇳 Dalian, China

CN052; 🇨🇳 Hengshui, China

CN008; 🇨🇳 Shenyang, China

CN032; 🇨🇳 Wuhan, China

CN012; 🇨🇳 Xi'an, China

CN066; 🇨🇳 Yichun, China

CN047; 🇨🇳 Yiyang, China

CN082; 🇨🇳 Wuhan, China

CN010; 🇨🇳 Xi'an, China

CN011; 🇨🇳 Xianyang, China

CN067; 🇨🇳 Yichun, China

CN081; 🇨🇳 Zhuozhou, China

CN071; 🇨🇳 Baoding, China

CN072; 🇨🇳 Baoding, China

CN083; 🇨🇳 Beijing, China

CN050; 🇨🇳 Binzhou, China

CN041; 🇨🇳 Changchun, China

CN029; 🇨🇳 Changzhi, China

CN044; 🇨🇳 Daqing, China

CN018; 🇨🇳 Daqing, China

CN063; 🇨🇳 Ha'erbin, China

CN045; 🇨🇳 Ha'erbin, China

CN030; 🇨🇳 Jinan, China

CN036; 🇨🇳 Hefei, China

CN002; 🇨🇳 Hengyang, China

CN084; 🇨🇳 Huaihua, China

CN069; 🇨🇳 Ji'an, China

CN040; 🇨🇳 Jiamusi, China

CN022; 🇨🇳 Jilin, China

CN058; 🇨🇳 Jilin, China

CN021; 🇨🇳 Jingdezhen, China

CN057; 🇨🇳 Jinzhou, China

CN075; 🇨🇳 Jiujiang, China

CN088; 🇨🇳 Jiujiang, China

CN014; 🇨🇳 Kaifeng, China

CN055; 🇨🇳 Lianyungang, China

CN013; 🇨🇳 Luohe, China

CN056; 🇨🇳 Mudanjiang, China

CN060; 🇨🇳 Mudanjiang, China

CN061; 🇨🇳 Mudanjiang, China

CN068; 🇨🇳 Nanchang, China

CN074; 🇨🇳 Luoyang, China

CN087; 🇨🇳 Luoyang, China

CN017; 🇨🇳 Shenyang, China

CN049; 🇨🇳 Sanming, China

CN048; 🇨🇳 Shenyang, China

CN006; 🇨🇳 Shenyang, China

CN005; 🇨🇳 Shenzhen, China

CN023; 🇨🇳 Siping, China

CN016; 🇨🇳 Suihua, China

CN028; 🇨🇳 Taiyuan, China

CN020; 🇨🇳 Tangshan, China

CN019; 🇨🇳 Tangshan, China

CN034; 🇨🇳 Tianjin, China

CN033; 🇨🇳 Tianjin, China

CN031; 🇨🇳 Xianning, China

CN009; 🇨🇳 Xianyang, China

CN064; 🇨🇳 Xinyu, China

CN065; 🇨🇳 Xinyu, China

CN004; 🇨🇳 Yancheng, China

CN038; 🇨🇳 Yuncheng, China

CN039; 🇨🇳 Zhenjiang, China

CN015; 🇨🇳 Zhumadian, China

CN053; 🇨🇳 Zibo, China

CN079; 🇨🇳 Chenzhou, China

CN076; 🇨🇳 Ha'erbin, China

CN046; 🇨🇳 Ha'erbin, China

CN024; 🇨🇳 Hegang, China

CN035; 🇨🇳 Hefei, China

CN025; 🇨🇳 Hegang, China

CN042; 🇨🇳 Hegang, China

CN077; 🇨🇳 Huanggang, China

CN070; 🇨🇳 Huaihua, China

CN085; 🇨🇳 Ji'an, China

CN062; 🇨🇳 Jilin, China

CN003; 🇨🇳 Nanjing, China