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Efficacy and safety of Ginkgo biloba diterpene lactone glumine injection in patients with acute ischemic stroke: a randomized, double-blind, multi-dose, placebo-controlled Phase ? exploratory trial

Efficacy and safety of Ginkgo biloba diterpene lactone glumine injection in patients with acute ischemic stroke: a randomized, double-blind, multi-dose, placebo-controlled Phase ? exploratory trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070949
Enrollment
Unknown
Registered
2023-04-27
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

acute ischemic stroke

Interventions

High-dose experimental group:Ginkgo diterpene lactone meglumine injection 3 doses +aspirin
Medium-dose experimental group:Ginkgo diterpene lactone meglumine injection 2 doses + ginkgo diterpene lactone meglumine injection simulator 1 dose + aspirin
Low-dose experimental group:Ginkgo diterpene lactone meglumine injection 1 dose + Ginkgo diterpene lactone meglumine injection simulator 2 doses + aspirin
Control placebo group:Ginkgo diterpene lactone meglumine injection simulator 3 doses + aspirin

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 40 = age = 80 years old, male or female; (2) Acute ischemic stroke within 4.5-48 hours after the onset of the disease was diagnosed by clear evidence; (3) The first onset, or the previous onset without relevant serious sequelae (mRS = 2 before this onset); (4) NIHSS score = 5 and = 24; (5) Understand and voluntarily sign the informed consent form for research.

Exclusion criteria

Exclusion criteria: (1) Non-vascular intracranial diseases (such as intracranial tumors, multiple sclerosis, etc.); (2) Imaging examination showed that the area of cerebral infarction was greater than 1/2 of the single lobe area; (3) The imaging examination showed that this cerebral infarction had post-infarction hemorrhage transformation; (4) Patients with contraindications to the use of ginkgo preparations or aspirin; (5) MRS was greater than 2 points before onset; (6) There was severe hepatic insufficiency or renal insufficiency before randomization; (7) Previous history of intracranial hemorrhage (such as ICH, SAH); (8) There is a history of gastrointestinal bleeding or major surgery in the past 90 days; (9) Suffer from serious organic disease, and the expected survival time is less than 90 days; (10) Pregnant women or women of childbearing age who have not taken effective contraceptive measures and have no pregnancy test records; (11) Other experimental drugs or instruments are being tested; (12) Unable to cooperate to complete 90-day event follow-up due to geographical or other reasons (such as alcoholism, drug abuse or dementia, serious mental illness, etc.).

Design outcomes

Primary

MeasureTime frame
national Institute of Health stroke scale (NIHSS);CT perfusion;

Secondary

MeasureTime frame
modified Rankin Scale (mRS);

Countries

China

Contacts

Public ContactHan Yan

Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine

hanyan.2006@aliyun.com+86 18917510069

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026