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
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
liver function tests	0, 14 days

Trial Locations

Locations (86)

CN051; 🇨🇳 Anyang, China

CN071; 🇨🇳 Baoding, China

CN072; 🇨🇳 Baoding, China

CN073; 🇨🇳 Baoding, China

CN027; 🇨🇳 Baotou, China

CN054; 🇨🇳 Baotou, China

CN001; 🇨🇳 Beijing, China

CN083; 🇨🇳 Beijing, China

CN050; 🇨🇳 Binzhou, China

CN080; 🇨🇳 Cangzhou, China

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