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Ischemic StrokePhase 4NCT01958957

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

A Phase 4 study testing Ginkgolides Meglumine Injection in people with Ischemic Stroke, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 86 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Ginkgolides Meglumine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,300 participants
Where
86 sitesChina
Study dates
Jun 2013to Oct 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

China86 sites

  • CN051

    Anyang, 455000

  • CN071

    Baoding, 071000

  • CN072

    Baoding, 071000

  • CN073

    Baoding, 071000

  • CN027

    Baotou, 014016

  • CN054

    Baotou, 150200

  • CN001

    Beijing, 100007

  • CN083

    Beijing, 100029

  • CN050

    Binzhou, 256603

  • CN080

    Cangzhou, 06100

  • CN041

    Changchun, 130000

  • CN043

    Changchun, 130022

  • CN029

    Changzhi, 046011

  • CN079

    Chenzhou, 423000

  • CN007

    Dalian, 116021

  • CN044

    Daqing, 163000

  • CN018

    Daqing, 163001

  • CN063

    Ha’erbin, 150001

  • CN045

    Ha’erbin, 150040

  • CN059

    Ha’erbin, 150056

  • CN046

    Ha’erbin, 150076

  • CN076

    Ha’erbin, 150080

  • CN078

    Handan, 056001

  • CN035

    Hefei, 230022

  • CN036

    Hefei, 230061

  • CN024

    Hegang, 154100

  • CN025

    Hegang, 154100

  • CN042

    Hegang, 154211

  • CN052

    Hengshui, 053000

  • CN002

    Hengyang, 421001

  • CN026

    Hohhot, 010010

  • CN070

    Huaihua, 418000

  • CN084

    Huaihua, 418000

  • CN077

    Huanggang, 438000

  • CN069

    Ji’an, 343000

  • CN085

    Ji’an, 343000

  • CN040

    Jiamusi

  • CN062

    Jilin City, 132000

  • CN022

    Jilin City, 132011

  • CN058

    Jilin City, 132011

  • CN030

    Jinan, 250012

  • CN021

    Jingdezhen, 333003

  • CN057

    Jinzhou, 121000

  • CN075

    Jiujiang, 332000

  • CN088

    Jiujiang, 332000

  • CN014

    Kaifeng, 475099

  • CN055

    Lianyungang, 222002

  • CN013

    Luohe, 462099

  • CN087

    Luoyang, 471000

  • CN074

    Luoyang, 471003

  • CN056

    Mudanjiang, 157000

  • CN060

    Mudanjiang, 157000

  • CN061

    Mudanjiang, 157000

  • CN068

    Nanchang, 330200

  • CN003

    Nanjing, 210005

  • CN049

    Sanming, 365000

  • CN048

    Shenyang, 110000

  • CN008

    Shenyang, 110032

  • CN006

    Shenyang, 110034

  • CN017

    Shenyang, 110091

  • CN005

    Shenzhen, 518034

  • CN023

    Siping, 136099

  • CN016

    Suihua, 151100

  • CN028

    Taiyuan, 030001

  • CN020

    Tangshan, 063001

  • CN019

    Tangshan, 063003

  • CN034

    Tianjin, 300100

  • CN033

    Tianjin, 300192

  • CN082

    Wuhan, 430060

  • CN032

    Wuhan, 430080

  • CN012

    Xi'an, 710001

  • CN010

    Xi'an, 710054

  • CN031

    Xianning, 437099

  • CN011

    Xianyang, 712021

  • CN009

    Xianyang, 712099

  • CN064

    Xinyu, 338000

  • CN065

    Xinyu, 338025

  • CN004

    Yancheng, 224001

  • CN066

    Yichun, 336000

  • CN067

    Yichun, 336000

  • CN047

    Yiyang, 413000

  • CN038

    Yuncheng, 044000

  • CN039

    Zhenjiang, 212001

  • CN015

    Zhumadian, 463000

  • CN081

    Zhuozhou, 072750

  • CN053

    Zibo, 255000

Other trials in China

About this study

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.

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.

Read the 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.

Conditions
Ischemic Stroke
Being tested
Ginkgolides Meglumine Injection
Keywords
ischemic stroke, safety, Ginkgolides Meglumine Injection
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ginkgolides Meglumine InjectionDrug

    25mg, intravenous drip, once a day. Number of Cycles: 14 days.

Study groups in NCT01958957
Study groupRoleWhat they receive
Ginkgolides Meglumine InjectionExperimentalIntravenous 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.
Receives: Drug: Ginkgolides Meglumine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Measured: 14 days

Secondary outcomes (9)

  1. vital signs after 10 minutes of stasis.

    Measured: 0，14 days

  2. Blood routine tests

    Measured: 0, 14 days

  3. ECG

    Measured: 0, 14 days

  4. Patient- reported outcomes,PRO

    Measured: 0, 14 days

  5. liver function tests

    Measured: 0, 14 days

  6. kidney function tests

    Measured: 0, 14 days

  7. urine routine tests

    Measured: 0, 14 days

  8. stool routine +occult blood tests

    Measured: 0, 14 days

  9. Coagulation function tests

    Measured: 0, 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01958957
Sponsor's protocol ID
201311BDY04V05
Status last verified
May 2013
First submitted
29 Sep 2013
Last updated
24 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ginkgolides Meglumine Injection in people with Ischemic Stroke, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 86 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01958957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.

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