A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke.
NCT ID: NCT01958957
Last Updated: 2014-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
6300 participants
INTERVENTIONAL
2013-06-30
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Ginkgolides Meglumine Injection
25mg, intravenous drip, once a day. Number of Cycles: 14 days.
Interventions
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Ginkgolides Meglumine Injection
25mg, intravenous drip, once a day. Number of Cycles: 14 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Bionovo Medicine Development Co., Ltd.
OTHER
Jiangsu Kanion Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Gao Ying, Doctor
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital, Beijing
Zhou Li
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital, Beijing
Locations
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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
CN044
Daqing, , China
CN018
Daqing, , China
CN078
Handan, , China
CN063
Ha’erbin, , China
CN045
Ha’erbin, , China
CN059
Ha’erbin, , China
CN046
Ha’erbin, , China
CN076
Ha’erbin, , China
CN035
Hefei, , China
CN036
Hefei, , China
CN024
Hegang, , China
CN025
Hegang, , China
CN042
Hegang, , China
CN052
Hengshui, , China
CN002
Hengyang, , China
CN026
Hohhot, , China
CN070
Huaihua, , China
CN084
Huaihua, , China
CN077
Huanggang, , China
CN040
Jiamusi, , China
CN062
Jilin, , China
CN022
Jilin, , China
CN058
Jilin, , China
CN030
Jinan, , China
CN021
Jingdezhen, , China
CN057
Jinzhou, , China
CN075
Jiujiang, , China
CN088
Jiujiang, , China
CN069
Ji’an, , China
CN085
Ji’an, , China
CN014
Kaifeng, , China
CN055
Lianyungang, , China
CN013
Luohe, , China
CN087
Luoyang, , China
CN074
Luoyang, , China
CN056
Mudanjiang, , China
CN060
Mudanjiang, , China
CN061
Mudanjiang, , China
CN068
Nanchang, , China
CN003
Nanjing, , China
CN049
Sanming, , China
CN048
Shenyang, , China
CN008
Shenyang, , China
CN006
Shenyang, , China
CN017
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
CN082
Wuhan, , China
CN032
Wuhan, , China
CN012
Xi'an, , China
CN010
Xi'an, , China
CN031
Xianning, , China
CN011
Xianyang, , China
CN009
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, , China
Countries
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Other Identifiers
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201311BDY04V05
Identifier Type: -
Identifier Source: org_study_id