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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
Sponsor: Dr. Willmar Schwabe GmbH & Co. KG
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.
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)
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-11-28
Completion Date
2027-12-31
Last Updated
2026-03-10
Healthy Volunteers
No
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
Standard of care (SoC) Group
Individualized therapy in accordance with treatment guideline from the Chinese Stroke Association
Locations (17)
Baotou Central Hospital
Baotou, China
Tiantan Hospital
Beijing, China
Benxi Central Hospital
Benxi, China
Affiliated Hospital of Chifeng University
Chifeng, China
Dalian Lvshunkou District Traditional Chinese Medicine Hospital
Dalian, China
Dalian University Affiliated Xinhua Hospital
Dalian, China
The Second Hospital of Hebei Medical University
Hebei, China
The First Affiliated Hospital of Jiamusi University
Jiamusi, China
Liaocheng People´s Hospital
Liaocheng, China
Liuzhou Workers´ Hospital
Liuchow, China
First Hospital of Shanxi Medical University
Shanxi, China
Second Hospital of Shanxi Medical University
Shanxi, China
Suining Central Hospital
Suining, China
Weifang People´s Hospiztal
Weifang, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Yantaishan Hospital
Yantai, China
Zibo Municipal Hospital
Zibo, China