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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ginkgolides Meglumine Injection
Sponsored by
Jiangsu Kanion Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, safety, Ginkgolides Meglumine Injection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CN051
  • CN071
  • CN072
  • CN073
  • CN027
  • CN054
  • CN001
  • CN083
  • CN050
  • CN080
  • CN041
  • CN043
  • CN029
  • CN079
  • CN007
  • CN044
  • CN018
  • CN063
  • CN045
  • CN059
  • CN046
  • CN076
  • CN078
  • CN035
  • CN036
  • CN024
  • CN025
  • CN042
  • CN052
  • CN002
  • CN070
  • CN084
  • CN077
  • CN026
  • CN069
  • CN085
  • CN040
  • CN062
  • CN022
  • CN058
  • CN030
  • CN021
  • CN057
  • CN075
  • CN088
  • CN014
  • CN055
  • CN013
  • CN087
  • CN074
  • CN056
  • CN060
  • CN061
  • CN068
  • CN003
  • CN049
  • CN048
  • CN008
  • CN006
  • CN017
  • CN005
  • CN023
  • CN016
  • CN028
  • CN020
  • CN019
  • CN034
  • CN033
  • CN082
  • CN032
  • CN012
  • CN010
  • CN031
  • CN011
  • CN009
  • CN064
  • CN065
  • CN004
  • CN066
  • CN067
  • CN047
  • CN038
  • CN039
  • CN015
  • CN081
  • CN053

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ginkgolides Meglumine Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

vital signs after 10 minutes of stasis.
Blood routine tests
ECG
Patient- reported outcomes,PRO
liver function tests
kidney function tests
urine routine tests
stool routine +occult blood tests
Coagulation function tests

Full Information

First Posted
September 29, 2013
Last Updated
December 23, 2014
Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01958957
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Kanion Pharmaceutical Co., Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, safety, Ginkgolides Meglumine Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginkgolides Meglumine Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ginkgolides Meglumine Injection
Intervention Description
25mg, intravenous drip, once a day. Number of Cycles: 14 days.
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
14 days
Secondary Outcome Measure Information:
Title
vital signs after 10 minutes of stasis.
Time Frame
0，14 days
Title
Blood routine tests
Time Frame
0, 14 days
Title
ECG
Time Frame
0, 14 days
Title
Patient- reported outcomes,PRO
Time Frame
0, 14 days
Title
liver function tests
Time Frame
0, 14 days
Title
kidney function tests
Time Frame
0, 14 days
Title
urine routine tests
Time Frame
0, 14 days
Title
stool routine +occult blood tests
Time Frame
0, 14 days
Title
Coagulation function tests
Time Frame
0, 14 days
Other Pre-specified Outcome Measures:
Title
NIH Stroke Scale，NIHSS
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao Ying, Doctor
Organizational Affiliation
Dongzhimen Hospital, Beijing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhou Li
Organizational Affiliation
Dongzhimen Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
CN051
City
Anyang
ZIP/Postal Code
455000
Country
China
Facility Name
CN071
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
CN072
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
CN073
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
CN027
City
Baotou
ZIP/Postal Code
014016
Country
China
Facility Name
CN054
City
Baotou
ZIP/Postal Code
150200
Country
China
Facility Name
CN001
City
Beijing
ZIP/Postal Code
100007
Country
China
Facility Name
CN083
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
CN050
City
Binzhou
ZIP/Postal Code
256603
Country
China
Facility Name
CN080
City
Cangzhou
ZIP/Postal Code
06100
Country
China
Facility Name
CN041
City
Changchun
ZIP/Postal Code
130000
Country
China
Facility Name
CN043
City
Changchun
ZIP/Postal Code
130022
Country
China
Facility Name
CN029
City
Changzhi
ZIP/Postal Code
046011
Country
China
Facility Name
CN079
City
Chenzhou
ZIP/Postal Code
423000
Country
China
Facility Name
CN007
City
Dalian
ZIP/Postal Code
116021
Country
China
Facility Name
CN044
City
Daqing
ZIP/Postal Code
163000
Country
China
Facility Name
CN018
City
Daqing
ZIP/Postal Code
163001
Country
China
Facility Name
CN063
City
Ha'erbin
ZIP/Postal Code
150001
Country
China
Facility Name
CN045
City
Ha'erbin
ZIP/Postal Code
150040
Country
China
Facility Name
CN059
City
Ha'erbin
ZIP/Postal Code
150056
Country
China
Facility Name
CN046
City
Ha'erbin
ZIP/Postal Code
150076
Country
China
Facility Name
CN076
City
Ha'erbin
ZIP/Postal Code
150080
Country
China
Facility Name
CN078
City
Handan
ZIP/Postal Code
056001
Country
China
Facility Name
CN035
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
CN036
City
Hefei
ZIP/Postal Code
230061
Country
China
Facility Name
CN024
City
Hegang
ZIP/Postal Code
154100
Country
China
Facility Name
CN025
City
Hegang
ZIP/Postal Code
154100
Country
China
Facility Name
CN042
City
Hegang
ZIP/Postal Code
154211
Country
China
Facility Name
CN052
City
Hengshui
ZIP/Postal Code
053000
Country
China
Facility Name
CN002
City
Hengyang
ZIP/Postal Code
421001
Country
China
Facility Name
CN070
City
Huaihua
ZIP/Postal Code
418000
Country
China
Facility Name
CN084
City
Huaihua
ZIP/Postal Code
418000
Country
China
Facility Name
CN077
City
Huanggang
ZIP/Postal Code
438000
Country
China
Facility Name
CN026
City
Huhehaote
ZIP/Postal Code
010010
Country
China
Facility Name
CN069
City
Ji'an
ZIP/Postal Code
343000
Country
China
Facility Name
CN085
City
Ji'an
ZIP/Postal Code
343000
Country
China
Facility Name
CN040
City
Jiamusi
Country
China
Facility Name
CN062
City
Jilin
ZIP/Postal Code
132000
Country
China
Facility Name
CN022
City
Jilin
ZIP/Postal Code
132011
Country
China
Facility Name
CN058
City
Jilin
ZIP/Postal Code
132011
Country
China
Facility Name
CN030
City
Jinan
ZIP/Postal Code
250012
Country
China
Facility Name
CN021
City
Jingdezhen
ZIP/Postal Code
333003
Country
China
Facility Name
CN057
City
Jinzhou
ZIP/Postal Code
121000
Country
China
Facility Name
CN075
City
Jiujiang
ZIP/Postal Code
332000
Country
China
Facility Name
CN088
City
Jiujiang
ZIP/Postal Code
332000
Country
China
Facility Name
CN014
City
Kaifeng
ZIP/Postal Code
475099
Country
China
Facility Name
CN055
City
Lianyungang
ZIP/Postal Code
222002
Country
China
Facility Name
CN013
City
Luohe
ZIP/Postal Code
462099
Country
China
Facility Name
CN087
City
Luoyang
ZIP/Postal Code
471000
Country
China
Facility Name
CN074
City
Luoyang
ZIP/Postal Code
471003
Country
China
Facility Name
CN056
City
Mudanjiang
ZIP/Postal Code
157000
Country
China
Facility Name
CN060
City
Mudanjiang
ZIP/Postal Code
157000
Country
China
Facility Name
CN061
City
Mudanjiang
ZIP/Postal Code
157000
Country
China
Facility Name
CN068
City
Nanchang
ZIP/Postal Code
330200
Country
China
Facility Name
CN003
City
Nanjing
ZIP/Postal Code
210005
Country
China
Facility Name
CN049
City
Sanming
ZIP/Postal Code
365000
Country
China
Facility Name
CN048
City
Shenyang
ZIP/Postal Code
110000
Country
China
Facility Name
CN008
City
Shenyang
ZIP/Postal Code
110032
Country
China
Facility Name
CN006
City
Shenyang
ZIP/Postal Code
110034
Country
China
Facility Name
CN017
City
Shenyang
ZIP/Postal Code
110091
Country
China
Facility Name
CN005
City
Shenzhen
ZIP/Postal Code
518034
Country
China
Facility Name
CN023
City
Siping
ZIP/Postal Code
136099
Country
China
Facility Name
CN016
City
Suihua
ZIP/Postal Code
151100
Country
China
Facility Name
CN028
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
CN020
City
Tangshan
ZIP/Postal Code
063001
Country
China
Facility Name
CN019
City
Tangshan
ZIP/Postal Code
063003
Country
China
Facility Name
CN034
City
Tianjin
ZIP/Postal Code
300100
Country
China
Facility Name
CN033
City
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
CN082
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
CN032
City
Wuhan
ZIP/Postal Code
430080
Country
China
Facility Name
CN012
City
Xi'an
ZIP/Postal Code
710001
Country
China
Facility Name
CN010
City
Xi'an
ZIP/Postal Code
710054
Country
China
Facility Name
CN031
City
Xianning
ZIP/Postal Code
437099
Country
China
Facility Name
CN011
City
Xianyang
ZIP/Postal Code
712021
Country
China
Facility Name
CN009
City
Xianyang
ZIP/Postal Code
712099
Country
China
Facility Name
CN064
City
Xinyu
ZIP/Postal Code
338000
Country
China
Facility Name
CN065
City
Xinyu
ZIP/Postal Code
338025
Country
China
Facility Name
CN004
City
Yancheng
ZIP/Postal Code
224001
Country
China
Facility Name
CN066
City
Yichun
ZIP/Postal Code
336000
Country
China
Facility Name
CN067
City
Yichun
ZIP/Postal Code
336000
Country
China
Facility Name
CN047
City
Yiyang
ZIP/Postal Code
413000
Country
China
Facility Name
CN038
City
Yuncheng
ZIP/Postal Code
044000
Country
China
Facility Name
CN039
City
Zhenjiang
ZIP/Postal Code
212001
Country
China
Facility Name
CN015
City
Zhumadian
ZIP/Postal Code
463000
Country
China
Facility Name
CN081
City
Zhuozhou
ZIP/Postal Code
072750
Country
China
Facility Name
CN053
City
Zibo
ZIP/Postal Code
255000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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