NCT07220538

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Dr. Willmar Schwabe GmbH & Co. KG · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ischemic Stroke Hospitalized
• Impairment, Cognitive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-28
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-10-24
• Last updated: 2026-03-10

Locations

17 sites across 1 country: China