Extract of Ginkgo Biloba Leaves Tablets 240 mg (2 x 40 mg, t.i.d.)
Drug3 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
NCT Number: NCT07220538
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.
Interested in participating?
Request Info55 year and older
All sexes
Interventional
Phase 4
The People's Hospital of Anyang City, Anyang, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Individualized therapy in accordance with treatment guideline from the Chinese Stroke Association
Time frame: From baseline to Week 26 (Visit 4) and Week 52 (Visit 6)
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].
Time frame: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)
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.
Time frame: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)
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
Time frame: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)
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.
Time frame: Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6)
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:
Lower scores indicate improvement, while higher scores reflect deterioration.
Time frame: Change from Baseline to Week 4 (Visit 1), Week 26 (Visit 4) and Week 52 (Visit 6)
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.
Time frame: Change from Baseline to Week 4 (Visit 1), Week 26 (Visit 4) and Week 52 (Visit 6)
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
Lower scores indicate better functional outcomes.
Time frame: Week 4, Week 12, Week 26, Week 38 and Week 52
Time frame: up to 52 weeks
Safety will be assessed by documenting the frequency and nature of adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) throughout the entire trial period. Investigators will record the number of participants experiencing each type of event, including details on severity, relationship to study treatment, and outcome.
Contact information is provided by the study sponsor or research team.
Clinical Project Manager
CONTACT
Senior Medical Advisor, M.D., Ph.D
CONTACT
Dr. Willmar Schwabe GmbH & Co. KG
Industry
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)
Acronym: GiCIIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00484549
Brain Diseases, Brain Diseases, Metabolic
Clermont-Ferrand, France
View Trial DetailsNCT07736885
Brain Diseases, Cardiovascular Diseases
Tianjin, Tianjin Municipality, China
View Trial DetailsNCT04897334
Brain Diseases, Cardiovascular Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT04916210
Arterial Occlusive Diseases, Arteriosclerosis
Phoenix, Arizona, United States
View Trial Details