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)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Baotou Central Hospital
RECRUITING
Baotou
Dalian Lvshunkou District Traditional Chinese Medicine Hospital
RECRUITING
Dalian
The First Affiliated Hospital of Jiamusi University
ACTIVE_NOT_RECRUITING
Jiamusi
Suining Central Hospital
ACTIVE_NOT_RECRUITING
Suining
Contact Information
Primary
Clinical Project Manager
anne-katrin.maly@schwabe.de
+497214005243
Backup
Senior Medical Advisor, M.D., Ph.D
marilia.soria@schwabe.de
+4972140059750
Time Frame
Start Date: 2025-11-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 400
Treatments
Experimental: 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
Sham_comparator: Standard of Care
Standard of Care (SoC) Group
Related Therapeutic Areas
Sponsors
Leads: Dr. Willmar Schwabe GmbH & Co. KG
Collaborators: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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