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RECRUITING
NCT07220538
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

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

OTHER

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