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Ischemic Stroke HospitalizedPhase 4GiCIISNCT07220538

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

A Phase 4 study testing Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) in people with Ischemic Stroke Hospitalized and Impairment, Cognitive, run by Dr. Willmar Schwabe GmbH & Co. KG at 34 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
34 sitesChina
Study dates
28 Nov 2025to 31 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

China34 sites

  • The People's Hospital of Anyang City

    Anyang

  • Baotou Central Hospital

    Baotou

  • Tiantan Hospital

    Beijing

  • Benxi Central Hospital

    Benxi

  • The First People's Hospital of Chenzhou

    Chenzhou

  • Affiliated Hospital of Chifeng University

    Chifeng

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian

  • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)

    Dalian

  • Dalian Lvshunkou District Traditional Chinese Medicine Hospital

    Dalian

  • Dalian University Affiliated Xinhua Hospital

    Dalian

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin

  • Affiliated Hospital of Hebei University

    Hebei

  • The Second Hospital of Hebei Medical University

    Hebei

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Henan

  • Huizhou First Hospital

    Huizhou

  • The First Affiliated Hospital of Jiamusi University

    Jiamusi

  • China-Japan Union Hospital of Jilin University

    Jilin City

  • Jiujiang No.1 People's Hospital

    Jiujiang

  • Liaocheng People´s Hospital

    Liaocheng

  • Liuzhou Workers´ Hospital

    Liuzhou

  • Luoyang Central Hospital

    Luoyang

  • Nanning First People's Hospital

    Nanning

  • Puyang Oilfield General Hospital

    Pujiang

  • Second Hospital of Shanxi Medical University

    Shanxi

  • Shanxi Cardiovascular Hospital

    Shanxi

  • The First People's Hospital Of Shenyang

    Shenyang

  • The People's Hospital of Liaoning Province

    Shenyang

  • Siping City Central People's Hospital

    Siping

  • Suining Central Hospital

    Suining

  • Weifang People´s Hospiztal

    Weifang

  • Zhongnan Hospital of Wuhan University

    Wuhan

  • Yantaishan Hospital

    Yantai

  • Zhumadian Central Hospital

    Zhumadian

  • Zibo Municipal Hospital

    Zibo

Other trials in China

About this study

Official title: Pragmatic Open-label, Parallel-group Clinical Trial on the Effectiveness of Extract of Ginkgo Biloba Leaves Tablets as add-on to Standard of Care in Participants With Cognitive Impairment After an Acute Ischemic Stroke (GiCIIS)

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:

Read more
  • 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.
Read the 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.

Being tested
Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.), Standard of care (SoC) Group
Keywords
Acute ischemic stroke, Cognitive Impairment
Medical subject headings
Cognitive Dysfunction, Ischemic Stroke

What participants receive

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

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

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

Study groups in NCT07220538
Study groupRoleWhat they receive
Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) add-on to standard of careExperimentalExtract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) add-on to standard of care
Receives: Drug: Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)
Standard of CareSham comparatorStandard of Care (SoC) Group
Receives: Other: Standard of care (SoC) Group

What is being measured

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

  1. Change in Montreal Cognitive Assessment (MoCA) Total Score

    The Montreal Cognitive Assessment (MoCA) is a validated screening tool for mild cognitive impairment. It assesses multiple cognitive domains including attention, executive functions, memory, language, visuospatial skills, conceptual thinking, calculation, and orientation. The test takes approximately 10 minutes to administer and is scored out of a maximum of 30 points. The total score is calculated by summing all sub-item scores, with an additional 1 point added for individuals with ≤12 years of education (maximum score remains 30). Higher scores indicate better cognitive performance. A score below 23 for individuals with ≤12 years of education, or below 22 for those with >12 years of education, is considered indicative of cognitive impairment [Wu et al., 2013].

    Measured: From baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

  2. Change in Cognitive Function Using Trail Making Test (TMT) Parts A and B

    The Trail Making Test (TMT) is a neuropsychological assessment that provides information on visual search, scanning, processing speed, mental flexibility, and executive functioning. It consists of two parts. Both parts consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both Arabic numerals (1 - 13) and Chinese numerals as in Part A. he test is administered on paper, and participants are instructed to complete the task as quickly and accurately as possible without lifting the pen. Performance is measured in seconds.

    Measured: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

  3. Change in Cognitive Processing Speed Using Symbol Digit Modalities Test (SDMT)

    The Symbol Digit Modalities Test (SDMT) is a validated neuropsychological test used to assess cognitive processing speed, attention, and visual-motor coordination. Participants are presented with a series of symbols, each paired with a digit, and are asked to match as many symbols to their corresponding digits as possible within a fixed time period (typically 90 seconds). Performance is measured by the number of correct symbol-digit matches completed (maximum 110). Higher scores indicate better cognitive processing speed and attention

    Measured: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

  4. Change in Verbal Fluency Performance Using Verbal Fluency Test (VFT)

    The VFT tests the verbal fluency, the patient is asked to name as many examples of one category, e.g. "fruits", "vegetables", "animal", as possible within one minute. Performance is assessed by counting the number of correct, non-repeated words, along with the number of errors, including incorrect responses and repetitions, which contribute to the total score. Higher scores indicate better verbal fluency and cognitive function.

    Measured: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

  5. Change in Clinical Global Impression of Change Using ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change)

    The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a validated clinician-rated instrument used to assess overall change in a participant's cognitive, functional, and behavioral status over time. It is based on a structured interview with both the participant and caregiver, incorporating clinical judgment and observation.

    The ADCS-CGIC uses a 7-point scale to rate change from baseline:

    1. - Marked improvement
    2. - Moderate improvement
    3. - Minimal improvement
    4. - No change
    5. - Minimal worsening
    6. - Moderate worsening
    7. - Marked worsening

    Lower scores indicate improvement, while higher scores reflect deterioration.

    Measured: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)

  6. Change in Neurological Impairment Using National Institutes of Health Stroke Scale (NIHSS)

    The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to assess the severity of neurological deficits in patients following a stroke. It consists of 11 items evaluating functions such as consciousness, vision, motor skills, sensation, language, and attention. Each item is scored individually, and the total score ranges from 0 to 42, with higher scores indicating more severe neurological impairment. A decrease in score over time reflects improvement in neurological function, while an increase indicates worsening impairment.

    Measured: Change from Baseline to Week 4 (Visit 1), Week 26 (Visit 4) and Week 52 (Visit 6)

  7. Change in Neurological Impairment Using Modified Rankin Scale (mRS)

    The Modified Rankin Scale (mRS) is a clinical tool for measuring the degree of disability or dependence in daily activities of people who have suffered a stroke. It assesses functional recovery and neurological impairment on a scale ranging from 0 to 6:

    0 - No symptoms at all

    1. - No significant disability despite symptoms; able to carry out all usual duties and activities
    2. - Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance
    3. - Moderate disability; requiring some help, but able to walk without assistance
    4. - Moderately severe disability; unable to walk without assistance, and unable to attend to own bodily needs without assistance
    5. - Severe disability: bedridden, incontinent, and requiring constant nursing care and attention
    6. - Dead

    Lower scores indicate better functional outcomes.

    Measured: Change from Baseline to Week 4 (Visit 1), Week 26 (Visit 4) and Week 52 (Visit 6)

  8. Any new stroke event (ischemic stroke or hemorrhagic stroke) at Week 4, Week 12, Week 26, Week 38 and Week 52.

    Measured: Week 4, Week 12, Week 26, Week 38 and Week 52

Timeline

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

  1. First posted24 Oct 2025
  2. Study start28 Nov 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220538
Sponsor's protocol ID
D.01.02.2.04
Other IDs
ChiCTR2500107051
Acronym
GiCIIS
Status last verified
Oct 2026
First submitted
14 Oct 2025
Last updated
30 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to ethical reasons and in terms of data protection law, raw data cannot be shared

Publications

  • Wu Y, Wang M, Ren M, Xu W. The effects of educational background on Montreal Cognitive Assessment screening for vascular cognitive impairment, no dementia, caused by ischemic stroke. J Clin Neurosci. 2013 Oct;20(10):1406-10. doi: 10.1016/j.jocn.2012.11.019. Epub 2013 Jul 24.

    PubMed 23891119

  • Liu L, Li Z, Zhou H, Duan W, Huo X, Xu W, Li S, Nie X, Liu H, Liu J, Sun D, Wei Y, Zhang G, Yuan W, Zheng L, Liu J, Wang D, Miao Z, Wang Y. Chinese Stroke Association guidelines for clinical management of ischaemic cerebrovascular diseases: executive summary and 2023 update. Stroke Vasc Neurol. 2023 Dec 29;8(6):e3. doi: 10.1136/svn-2023-002998.

    PubMed 38158224

  • 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.

    PubMed 22459264

  • 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.

    PubMed 37125534

  • 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.

    PubMed 37063270

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.) in people with Ischemic Stroke Hospitalized and Impairment, Cognitive, run by Dr. Willmar Schwabe GmbH & Co. KG at 34 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 4 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in Montreal Cognitive Assessment (MoCA) Total Score (time frame: From baseline to Week 26 (Visit 4) and Week 52 (Visit 6)). The study lists 8 primary outcomes in all. 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 NCT07220538, which also lists 5 linked publications.

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 30 Oct 2026.

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