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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01958957

Enrollment

6300

Registered

2013-10-09

Start date

2013-06-30

Completion date

2014-10-31

Last updated

2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

ischemic stroke, safety, Ginkgolides Meglumine Injection

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.

Interventions

DRUGGinkgolides Meglumine Injection

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Adverse Events	14 days

Secondary

Measure	Time frame
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
kidney function tests	0, 14 days
urine routine tests	0, 14 days
stool routine +occult blood tests	0, 14 days
Coagulation function tests	0, 14 days
liver function tests	0, 14 days

Other

Measure	Time frame
NIH Stroke Scale，NIHSS	baseline

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026