Status:
RECRUITING
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Lead Sponsor:
Dr. Willmar Schwabe GmbH & Co. KG
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Ischemic Stroke Hospitalized
Impairment, Cognitive
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn if Extract of Ginkgo Biloba Leaves Tablets help improve thinking and memory in people aged 55 years and older who had an ischemic stroke (a type of stroke c...
Detailed Description
This is a prospective, multicenter, pragmatic, open-label, parallel-group, randomized clinical trial to investigate the effectiveness and safety of Extract of Ginkgo Biloba Leaves Tablets as add-on to...
Eligibility Criteria
Inclusion
- Male and female participants aged ≥ 55 years who gave their informed consent.
- Non-disabling overt acute ischemic stroke (NIHSS (National Institutes of Health Stroke Scale) ≤ 5, mRS (Modified Rankin Scale) ≤ 2 at the day of screening) confirmed by magnetic resonance imaging, and at least 7 but no longer than 14 days before baseline.
- Cognitive impairment (MoCA (Montreal Cognitive Assessment)) total score (corrected) \< 23 for participants with up to 12 years of education, or MoCA total score \< 22 if more than 12 years of education).
- Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires and undergo neuropsychological testing.
Exclusion
- Participation in another experimental drug trial at the same time or within the past 4 weeks before enrollment.
- Aphasia, dysarthria, apraxia or paresis of the dominant upper extremity, severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the participant from cooperating adequately in the trial or that may interfere with neuropsychological test performance.
- Pre-stroke cognitive impairment (16-item Informant Questionnaire on Cognitive Decline (IQCODE) score ≥ 3.3), preexisting major neurocognitive disorder (e. g., dementia due to Alzheimer's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia).
- Cardiogenic ischemic stroke, atrial fibrillation, or any other conditions that require the intake of anticoagulants.
- Conditions that require the administration of thrombolytics at day of Screening or Visit 1.
- Index acute ischemic stroke with hemorrhagic transformation.
- Intake of traditional Chinese medicines.
- Major neurological disorder, including intracranial hemorrhage, delirium, Parkinson's disease, brain tumor, alcohol-associated brain damage, infectious CNS disease, epilepsy, recent brain trauma, subdural hematoma, HIV-associated cognitive disorder, Huntington's disease, Pick's disease, Wilson's disease, normal pressure hydrocephalus, hydrocephalus, progressive supra-nuclear palsy, Creutzfeldt-Jakob disease, etc.
- Major depression or generalized anxiety disorder.
- Active malignant disease.
- Alcohol addiction or substance abuse.
- Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under trial.
- Any circumstances that prevent the participant to be followed up at the scheduled intervals. Hospitalization of the participant for long-term treatment or nursing home placement for bedside care (assisted living facility residence or stay in a rehabilitation facility is acceptable if the participant is not bedridden and does not need general bedside nursing, and if an informant is available who sees the participant on a regular basis and accompanies him/her to the trial visits).
- Severe comorbidity with life expectancy \< 12 months.
Key Trial Info
Start Date :
November 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07220538
Start Date
November 28 2025
End Date
December 31 2027
Last Update
December 15 2025
Active Locations (4)
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1
Baotou Central Hospital
Baotou, China
2
Dalian Lvshunkou District Traditional Chinese Medicine Hospital
Dalian, China
3
The First Affiliated Hospital of Jiamusi University
Jiamusi, China
4
Suining Central Hospital
Suining, China