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

Ischemic Stroke Clinical Trial

Official title:

A Multicenter Safety Clinical Trial of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke With Syndrome of Intermingled Phlegm and Blood Stasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958957
• Other study ID #: 201311BDY04V05
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2013
• Last updated: December 23, 2014
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2013
• Source: Jiangsu Kanion Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6300
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Ginkgolides Meglumine Injection
25mg, intravenous drip, once a day. Number of Cycles: 14 days.

Locations

Country	Name	City	State
China	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	CN041	Changchun
China	CN043	Changchun
China	CN029	Changzhi
China	CN079	Chenzhou
China	CN007	Dalian
China	CN018	Daqing
China	CN044	Daqing
China	CN045	Ha'erbin
China	CN046	Ha'erbin
China	CN059	Ha'erbin
China	CN063	Ha'erbin
China	CN076	Ha'erbin
China	CN078	Handan
China	CN035	Hefei
China	CN036	Hefei
China	CN024	Hegang
China	CN025	Hegang
China	CN042	Hegang
China	CN052	Hengshui
China	CN002	Hengyang
China	CN070	Huaihua
China	CN084	Huaihua
China	CN077	Huanggang
China	CN026	Huhehaote
China	CN069	Ji'an
China	CN085	Ji'an
China	CN040	Jiamusi
China	CN022	Jilin
China	CN058	Jilin
China	CN062	Jilin
China	CN030	Jinan
China	CN021	Jingdezhen
China	CN057	Jinzhou
China	CN075	Jiujiang
China	CN088	Jiujiang
China	CN014	Kaifeng
China	CN055	Lianyungang
China	CN013	Luohe
China	CN074	Luoyang
China	CN087	Luoyang
China	CN056	Mudanjiang
China	CN060	Mudanjiang
China	CN061	Mudanjiang
China	CN068	Nanchang
China	CN003	Nanjing
China	CN049	Sanming
China	CN006	Shenyang
China	CN008	Shenyang
China	CN017	Shenyang
China	CN048	Shenyang
China	CN005	Shenzhen
China	CN023	Siping
China	CN016	Suihua
China	CN028	Taiyuan
China	CN019	Tangshan
China	CN020	Tangshan
China	CN033	Tianjin
China	CN034	Tianjin
China	CN032	Wuhan
China	CN082	Wuhan
China	CN010	Xi'an
China	CN012	Xi'an
China	CN031	Xianning
China	CN009	Xianyang
China	CN011	Xianyang
China	CN064	Xinyu
China	CN065	Xinyu
China	CN004	Yancheng
China	CN066	Yichun
China	CN067	Yichun
China	CN047	Yiyang
China	CN038	Yuncheng
China	CN039	Zhenjiang
China	CN015	Zhumadian
China	CN081	Zhuozhou
China	CN053	Zibo

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIH Stroke Scale,NIHSS		baseline	No
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