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

December 23, 2014 updated by: Jiangsu Kanion Pharmaceutical Co., Ltd

A Multicenter Safety Clinical Trial of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Anyang, China, 455000
        • CN051
      • Baoding, China, 071000
        • CN071
      • Baoding, China, 071000
        • CN072
      • Baoding, China, 071000
        • CN073
      • Baotou, China, 014016
        • CN027
      • Baotou, China, 150200
        • CN054
      • Beijing, China, 100007
        • CN001
      • Beijing, China, 100029
        • CN083
      • Binzhou, China, 256603
        • CN050
      • Cangzhou, China, 06100
        • CN080
      • Changchun, China, 130000
        • CN041
      • Changchun, China, 130022
        • CN043
      • Changzhi, China, 046011
        • CN029
      • Chenzhou, China, 423000
        • CN079
      • Dalian, China, 116021
        • CN007
      • Daqing, China, 163000
        • CN044
      • Daqing, China, 163001
        • CN018
      • Ha'erbin, China, 150001
        • CN063
      • Ha'erbin, China, 150040
        • CN045
      • Ha'erbin, China, 150056
        • CN059
      • Ha'erbin, China, 150076
        • CN046
      • Ha'erbin, China, 150080
        • CN076
      • Handan, China, 056001
        • CN078
      • Hefei, China, 230022
        • CN035
      • Hefei, China, 230061
        • CN036
      • Hegang, China, 154100
        • CN024
      • Hegang, China, 154100
        • CN025
      • Hegang, China, 154211
        • CN042
      • Hengshui, China, 053000
        • CN052
      • Hengyang, China, 421001
        • CN002
      • Huaihua, China, 418000
        • CN070
      • Huaihua, China, 418000
        • CN084
      • Huanggang, China, 438000
        • CN077
      • Huhehaote, China, 010010
        • CN026
      • Ji'an, China, 343000
        • CN069
      • Ji'an, China, 343000
        • CN085
      • Jiamusi, China
        • CN040
      • Jilin, China, 132000
        • CN062
      • Jilin, China, 132011
        • CN022
      • Jilin, China, 132011
        • CN058
      • Jinan, China, 250012
        • CN030
      • Jingdezhen, China, 333003
        • CN021
      • Jinzhou, China, 121000
        • CN057
      • Jiujiang, China, 332000
        • CN075
      • Jiujiang, China, 332000
        • CN088
      • Kaifeng, China, 475099
        • CN014
      • Lianyungang, China, 222002
        • CN055
      • Luohe, China, 462099
        • CN013
      • Luoyang, China, 471000
        • CN087
      • Luoyang, China, 471003
        • CN074
      • Mudanjiang, China, 157000
        • CN056
      • Mudanjiang, China, 157000
        • CN060
      • Mudanjiang, China, 157000
        • CN061
      • Nanchang, China, 330200
        • CN068
      • Nanjing, China, 210005
        • CN003
      • Sanming, China, 365000
        • CN049
      • Shenyang, China, 110000
        • CN048
      • Shenyang, China, 110032
        • CN008
      • Shenyang, China, 110034
        • CN006
      • Shenyang, China, 110091
        • CN017
      • Shenzhen, China, 518034
        • CN005
      • Siping, China, 136099
        • CN023
      • Suihua, China, 151100
        • CN016
      • Taiyuan, China, 030001
        • CN028
      • Tangshan, China, 063001
        • CN020
      • Tangshan, China, 063003
        • CN019
      • Tianjin, China, 300100
        • CN034
      • Tianjin, China, 300192
        • CN033
      • Wuhan, China, 430060
        • CN082
      • Wuhan, China, 430080
        • CN032
      • Xi'an, China, 710001
        • CN012
      • Xi'an, China, 710054
        • CN010
      • Xianning, China, 437099
        • CN031
      • Xianyang, China, 712021
        • CN011
      • Xianyang, China, 712099
        • CN009
      • Xinyu, China, 338000
        • CN064
      • Xinyu, China, 338025
        • CN065
      • Yancheng, China, 224001
        • CN004
      • Yichun, China, 336000
        • CN066
      • Yichun, China, 336000
        • CN067
      • Yiyang, China, 413000
        • CN047
      • Yuncheng, China, 044000
        • CN038
      • Zhenjiang, China, 212001
        • CN039
      • Zhumadian, China, 463000
        • CN015
      • Zhuozhou, China, 072750
        • CN081
      • Zibo, China, 255000
        • CN053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ginkgolides Meglumine Injection
25mg, intravenous drip, once a day. Number of Cycles: 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
vital signs after 10 minutes of stasis.
Time Frame: 0，14 days
0，14 days
Blood routine tests
Time Frame: 0, 14 days
0, 14 days
ECG
Time Frame: 0, 14 days
0, 14 days
Patient- reported outcomes,PRO
Time Frame: 0, 14 days
0, 14 days
liver function tests
Time Frame: 0, 14 days
0, 14 days
kidney function tests
Time Frame: 0, 14 days
0, 14 days
urine routine tests
Time Frame: 0, 14 days
0, 14 days
stool routine +occult blood tests
Time Frame: 0, 14 days
0, 14 days
Coagulation function tests
Time Frame: 0, 14 days
0, 14 days

Other Outcome Measures

Outcome Measure
Time Frame
NIH Stroke Scale，NIHSS
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Kanion Pharmaceutical Co., Ltd

Collaborators

Beijing Bionovo Medicine Development Co., Ltd.

Investigators

  • Principal Investigator: Gao Ying, Doctor, Dongzhimen Hospital, Beijing
  • Principal Investigator: Zhou Li, Dongzhimen Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 29, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201311BDY04V05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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