A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke.
A Multicenter Safety Clinical Trial of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke With Syndrome of Intermingled Phlegm and Blood Stasis.
1 other identifier
interventional
6,300
1 country
86
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2013
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 29, 2013
CompletedFirst Posted
Study publicly available on registry
October 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 24, 2014
May 1, 2013
1.3 years
September 29, 2013
December 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
14 days
Secondary Outcomes (9)
vital signs after 10 minutes of stasis.
0，14 days
Blood routine tests
0, 14 days
ECG
0, 14 days
Patient- reported outcomes,PRO
0, 14 days
liver function tests
0, 14 days
- +4 more secondary outcomes
Other Outcomes (1)
NIH Stroke Scale，NIHSS
baseline
Study Arms (1)
Ginkgolides Meglumine Injection
EXPERIMENTALIntravenous 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.
Interventions
25mg, intravenous drip, once a day. Number of Cycles: 14 days.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
CN051
Anyang, 455000, China
CN071
Baoding, 071000, China
CN072
Baoding, 071000, China
CN073
Baoding, 071000, China
CN027
Baotou, 014016, China
CN054
Baotou, 150200, China
CN001
Beijing, 100007, China
CN083
Beijing, 100029, China
CN050
Binzhou, 256603, China
CN080
Cangzhou, 06100, China
CN041
Changchun, 130000, China
CN043
Changchun, 130022, China
CN029
Changzhi, 046011, China
CN079
Chenzhou, 423000, China
CN007
Dalian, 116021, China
CN044
Daqing, 163000, China
CN018
Daqing, 163001, China
CN078
Handan, 056001, China
CN063
Ha’erbin, 150001, China
CN045
Ha’erbin, 150040, China
CN059
Ha’erbin, 150056, China
CN046
Ha’erbin, 150076, China
CN076
Ha’erbin, 150080, China
CN035
Hefei, 230022, China
CN036
Hefei, 230061, China
CN024
Hegang, 154100, China
CN025
Hegang, 154100, China
CN042
Hegang, 154211, China
CN052
Hengshui, 053000, China
CN002
Hengyang, 421001, China
CN026
Hohhot, 010010, China
CN070
Huaihua, 418000, China
CN084
Huaihua, 418000, China
CN077
Huanggang, 438000, China
CN040
Jiamusi, China
CN062
Jilin, 132000, China
CN022
Jilin, 132011, China
CN058
Jilin, 132011, China
CN030
Jinan, 250012, China
CN021
Jingdezhen, 333003, China
CN057
Jinzhou, 121000, China
CN075
Jiujiang, 332000, China
CN088
Jiujiang, 332000, China
CN069
Ji’an, 343000, China
CN085
Ji’an, 343000, China
CN014
Kaifeng, 475099, China
CN055
Lianyungang, 222002, China
CN013
Luohe, 462099, China
CN087
Luoyang, 471000, China
CN074
Luoyang, 471003, China
CN056
Mudanjiang, 157000, China
CN060
Mudanjiang, 157000, China
CN061
Mudanjiang, 157000, China
CN068
Nanchang, 330200, China
CN003
Nanjing, 210005, China
CN049
Sanming, 365000, China
CN048
Shenyang, 110000, China
CN008
Shenyang, 110032, China
CN006
Shenyang, 110034, China
CN017
Shenyang, 110091, China
CN005
Shenzhen, 518034, China
CN023
Siping, 136099, China
CN016
Suihua, 151100, China
CN028
Taiyuan, 030001, China
CN020
Tangshan, 063001, China
CN019
Tangshan, 063003, China
CN034
Tianjin, 300100, China
CN033
Tianjin, 300192, China
CN082
Wuhan, 430060, China
CN032
Wuhan, 430080, China
CN012
Xi'an, 710001, China
CN010
Xi'an, 710054, China
CN031
Xianning, 437099, China
CN011
Xianyang, 712021, China
CN009
Xianyang, 712099, China
CN064
Xinyu, 338000, China
CN065
Xinyu, 338025, China
CN004
Yancheng, 224001, China
CN066
Yichun, 336000, China
CN067
Yichun, 336000, China
CN047
Yiyang, 413000, China
CN038
Yuncheng, 044000, China
CN039
Zhenjiang, 212001, China
CN015
Zhumadian, 463000, China
CN081
Zhuozhou, 072750, China
CN053
Zibo, 255000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gao Ying, Doctor
Dongzhimen Hospital, Beijing
- PRINCIPAL INVESTIGATOR
Zhou Li
Dongzhimen Hospital, Beijing
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2013
First Posted
October 9, 2013
Study Start
June 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 24, 2014
Record last verified: 2013-05