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

NCT ID: NCT07220538

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-28
• Study Completion Date: 2027-12-31

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 caused by a blocked blood vessel in the brain). It will also look at how safe the Extract of Ginkgo Biloba Leaves Tablets are.

The main questions it aims to answer are:

• Do the Extract of Ginkgo Biloba Leaves Tablets help people with memory or thinking problems after an ischemic stroke?
• What medical problems do people have when taking the Extract of Ginkgo Biloba Leaves Tablets ? Researchers will compare people who take the Extract of Ginkgo Biloba Leaves Tablets along with their usual post-stroke treatment to people who only receive their usual post-stroke treatment.

Participants will:

• Have had an ischemic stroke confirmed by MRI (Magnet Resonance Imaging, a magnetic scan that helps seeing inside the body in great detail) 7 to 14 days before joining the study
• Take Extract of Ginkgo Biloba Leaves Tablets (240 mg per day) in addition to usual post-stroke treatment for 12 months, or receive only usual post-stroke treatment for 12 months
• Be treated initially at hospitals across China
• Visit the clinic 4, 26, and 52 weeks following the baseline for checkups and tests, and receive follow-up calls after 12 and 38 weeks.

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 standard of care in participants with cognitive impairment after an acute ischemic stroke (AIS). The trial will be conducted at hospitals across China. Participants that had had a non-disabling overt AIS (i. e., NIHSS (National Institutes of Health Stroke Scale) ≤ 5, mRS (Modified Rankin Scale) ≤ 2 at the day of screening), confirmed by MRI (magnetic resonance imaging), 7 to 14 days before screening will be randomized 1:1 to Extract of Ginkgo Biloba Leaves Tablets (240 mg total dose per day, (3 x (2 x 40 mg)) in addition to standard of care or standard of care alone. The total duration of the trial will be 52 weeks per trial participant.

Conditions

Ischemic Stroke Hospitalized; Impairment, Cognitive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) add-on to standard of care

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) add-on to standard of care

Group Type: EXPERIMENTAL

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)

Intervention Type: DRUG

3 x 2 film-coated tablets with 40 mg Extract of Ginkgo Biloba Leaves Tablets daily for 52 weeks plus standard of care in accordance with treatment guidelines

Standard of Care

Standard of Care (SoC) Group

Group Type: SHAM_COMPARATOR

Standard of care (SoC) Group

Intervention Type: OTHER

Individualized therapy in accordance with treatment guideline from the Chinese Stroke Association

Interventions

Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)

3 x 2 film-coated tablets with 40 mg Extract of Ginkgo Biloba Leaves Tablets daily for 52 weeks plus standard of care in accordance with treatment guidelines

Intervention Type: DRUG

Standard of care (SoC) Group

Individualized therapy in accordance with treatment guideline from the Chinese Stroke Association

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male and female participants aged ≥ 55 years who gave their informed consent.

2. 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.

3. 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).

4. Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires and undergo neuropsychological testing.

Exclusion Criteria

1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrollment.

2. 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.

3. 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).

4. Cardiogenic ischemic stroke, atrial fibrillation, or any other conditions that require the intake of anticoagulants.

5. Conditions that require the administration of thrombolytics at day of Screening or Visit 1.

6. Index acute ischemic stroke with hemorrhagic transformation.

7. Intake of traditional Chinese medicines.

8. 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.

9. Major depression or generalized anxiety disorder.

10. Active malignant disease.

11. Alcohol addiction or substance abuse.

12. Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under trial.

13. 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).

14. Severe comorbidity with life expectancy < 12 months.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Dr. Willmar Schwabe GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petra Klement

Role: STUDY_DIRECTOR

Dr. Willmar Schwabe GmbH & Co. KG

Locations

Baotou Central Hospital

Baotou, , China

Site Status: RECRUITING

Dalian Lvshunkou District Traditional Chinese Medicine Hospital

Dalian, , China

Site Status: RECRUITING

The First Affiliated Hospital of Jiamusi University

Jiamusi, , China

Site Status: ACTIVE_NOT_RECRUITING

Suining Central Hospital

Suining, , China

Site Status: ACTIVE_NOT_RECRUITING

Countries

China

Central Contacts

Clinical Project Manager

Role: CONTACT

anne-katrin.maly@schwabe.de

+497214005243

Senior Medical Advisor, M.D., Ph.D

Role: CONTACT

marilia.soria@schwabe.de

+4972140059750

References

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Reference Type: BACKGROUND

PMID: 23891119 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 38158224 (View on PubMed)

Herrschaft H, Nacu A, Likhachev S, Sholomov I, Hoerr R, Schlaefke S. Ginkgo biloba extract EGb 761(R) in dementia with neuropsychiatric features: a randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240 mg. J Psychiatr Res. 2012 Jun;46(6):716-23. doi: 10.1016/j.jpsychires.2012.03.003. Epub 2012 Mar 27.

Reference Type: BACKGROUND

PMID: 22459264 (View on PubMed)

El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.

Reference Type: BACKGROUND

PMID: 37125534 (View on PubMed)

Cui M, You T, Zhao Y, Liu R, Guan Y, Liu J, Liu X, Wang X, Dong Q. Ginkgo biloba extract EGb 761(R) improves cognition and overall condition after ischemic stroke: Results from a pilot randomized trial. Front Pharmacol. 2023 Mar 29;14:1147860. doi: 10.3389/fphar.2023.1147860. eCollection 2023.

Reference Type: BACKGROUND

PMID: 37063270 (View on PubMed)

Other Identifiers

ChiCTR2500107051

Identifier Type: REGISTRY

Identifier Source: secondary_id

D.01.02.2.04

Identifier Type: -

Identifier Source: org_study_id