Clinical trial NCT01958957: A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: ischemic stroke
safety
Ginkgolides Meglumine Injection
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2013-10-09
Enrollment: 6300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 14 days
Secondary outcomes:
measure: vital signs after 10 minutes of stasis.
timeFrame: 0，14 days
measure: Blood routine tests
timeFrame: 0, 14 days
measure: ECG
timeFrame: 0, 14 days
measure: Patient- reported outcomes,PRO
timeFrame: 0, 14 days
measure: liver function tests
timeFrame: 0, 14 days
measure: kidney function tests
timeFrame: 0, 14 days
measure: urine routine tests
timeFrame: 0, 14 days
measure: stool routine +occult blood tests
timeFrame: 0, 14 days
measure: Coagulation function tests
timeFrame: 0, 14 days
Other outcomes:
measure: NIH Stroke Scale，NIHSS
timeFrame: baseline
Locations:
city: Anyang
country: China
facility: CN051
city: Baoding
country: China
facility: CN071
city: Baoding
country: China
facility: CN072
city: Baoding
country: China
facility: CN073
city: Baotou
country: China
facility: CN027
city: Baotou
country: China
facility: CN054
city: Beijing
country: China
facility: CN001
city: Beijing
country: China
facility: CN083
city: Binzhou
country: China
facility: CN050
city: Cangzhou
country: China
facility: CN080
city: Changchun
country: China
facility: CN041
city: Changchun
country: China
facility: CN043
city: Changzhi
country: China
facility: CN029
city: Chenzhou
country: China
facility: CN079
city: Dalian
country: China
facility: CN007
city: Daqing
country: China
facility: CN044
city: Daqing
country: China
facility: CN018
city: Ha'erbin
country: China
facility: CN063
city: Ha'erbin
country: China
facility: CN045
city: Ha'erbin
country: China
facility: CN059
city: Ha'erbin
country: China
facility: CN046
city: Ha'erbin
country: China
facility: CN076
city: Handan
country: China
facility: CN078
city: Hefei
country: China
facility: CN035
city: Hefei
country: China
facility: CN036
city: Hegang
country: China
facility: CN024
city: Hegang
country: China
facility: CN025
city: Hegang
country: China
facility: CN042
city: Hengshui
country: China
facility: CN052
city: Hengyang
country: China
facility: CN002
city: Huaihua
country: China
facility: CN070
city: Huaihua
country: China
facility: CN084
city: Huanggang
country: China
facility: CN077
city: Huhehaote
country: China
facility: CN026
city: Ji'an
country: China
facility: CN069
city: Ji'an
country: China
facility: CN085
city: Jiamusi
country: China
facility: CN040
city: Jilin
country: China
facility: CN062
city: Jilin
country: China
facility: CN022
city: Jilin
country: China
facility: CN058
city: Jinan
country: China
facility: CN030
city: Jingdezhen
country: China
facility: CN021
city: Jinzhou
country: China
facility: CN057
city: Jiujiang
country: China
facility: CN075
city: Jiujiang
country: China
facility: CN088
city: Kaifeng
country: China
facility: CN014
city: Lianyungang
country: China
facility: CN055
city: Luohe
country: China
facility: CN013
city: Luoyang
country: China
facility: CN087
city: Luoyang
country: China
facility: CN074
city: Mudanjiang
country: China
facility: CN056
city: Mudanjiang
country: China
facility: CN060
city: Mudanjiang
country: China
facility: CN061
city: Nanchang
country: China
facility: CN068
city: Nanjing
country: China
facility: CN003
city: Sanming
country: China
facility: CN049
city: Shenyang
country: China
facility: CN048
city: Shenyang
country: China
facility: CN008
city: Shenyang
country: China
facility: CN006
city: Shenyang
country: China
facility: CN017
city: Shenzhen
country: China
facility: CN005
city: Siping
country: China
facility: CN023
city: Suihua
country: China
facility: CN016
city: Taiyuan
country: China
facility: CN028
city: Tangshan
country: China
facility: CN020
city: Tangshan
country: China
facility: CN019
city: Tianjin
country: China
facility: CN034
city: Tianjin
country: China
facility: CN033
city: Wuhan
country: China
facility: CN082
city: Wuhan
country: China
facility: CN032
city: Xi'an
country: China
facility: CN012
city: Xi'an
country: China
facility: CN010
city: Xianning
country: China
facility: CN031
city: Xianyang
country: China
facility: CN011
city: Xianyang
country: China
facility: CN009
city: Xinyu
country: China
facility: CN064
city: Xinyu
country: China
facility: CN065
city: Yancheng
country: China
facility: CN004
city: Yichun
country: China
facility: CN066
city: Yichun
country: China
facility: CN067
city: Yiyang
country: China
facility: CN047
city: Yuncheng
country: China
facility: CN038
city: Zhenjiang
country: China
facility: CN039
city: Zhumadian
country: China
facility: CN015
city: Zhuozhou
country: China
facility: CN081
city: Zibo
country: China
facility: CN053
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Gao Ying, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital, Beijing
name: Zhou Li
role: PRINCIPAL_INVESTIGATOR
References: