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)

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.

开始日期2025-11-28

申办/合作机构

Dr. Willmar Schwabe GmbH & Co. KG

[+1]

CTIS2025-521744-37-00

/ Recruiting临床3期

Multi-centre, double-blind, placebo-controlled, randomised trial to prove the efficacy and safety of Silexan® (WS®1265) in patients with a major depressive episode of mild to moderate severity

开始日期2025-11-17

申办/合作机构

Dr. Willmar Schwabe GmbH & Co. KG

CTIS2024-517199-39-00

/ Active, not recruiting临床2期

A RANDOMIZED, PLACEBO-CONTROLLED, TRIPLE-BLIND CLINICAL TRIAL TO INVESTIGATE TREATMENT EFFECTS AND SAFETY OF GINKGO BILOBA EXTRACT EGB 761® IN PARTICIPANTS WITH COGNITIVE IMPAIRMENT ASSOCIATED WITH POST-COVID-19 SYNDROME

开始日期2025-03-19

申办/合作机构

Dr. Willmar Schwabe GmbH & Co. KG

100 项与 Dr. Willmar Schwabe GmbH & Co. KG 相关的临床结果

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项与 Dr. Willmar Schwabe GmbH & Co. KG 相关的文献（医药）

2025-11-01·PHYTOMEDICINE

Network pharmacology to elucidate the role of phytotherapy in neurocognitive disorders

Review

作者: Barth, Stephan W ; Efferth, Thomas

BACKGROUND:

To date, there are no entirely satisfactory drugs available to treat neurocognitive disorders. In light of the increasing incidences of these disorders in societies with aging populations, there is an urgent need to further improve treatment options.

HYPOTHESIS:

Phytotherapy modulates diseases and symptoms by addressing multiple rather than single targets. Therefore, phytotherapy might be suited to treat complex diseases such as neurocognitive disorders.

METHODS AND BACKGROUND:

We performed a systematic review of the literature with defined search terms using the PubMed database. The search terms were: [(network pharmacology) OR (systems pharmacology) OR (microarray) OR (proteomic) OR (metabolomic) OR (transcriptomic) OR (RNA-seq)] AND [Alzheimer) OR (dementia)]. These search strings were connected with [(herbal) OR (botanical)] for polyherbal formulations and [(phytochemical) OR (natural product)] for single-herb preparations. Systems biology focuses on the human organism as dynamic networks that cooperate in an orchestrated manner in the healthy as well as in the diseased body. The diseasome concept integrates disease phenotypes with hierarchical networks across various biological levels-organ networks, cellular networks, and signaling networks. Network pharmacology aims to interfere with such networks to treat complex, multifactorial diseases. Diseases may be caused by exposure to external factors harmful to health (exposomes). Phytotherapy might beneficially influence diseasomes thus restoring disturbed networks. Here, the "phytome" which integrates herbal drug ingredients into the exposome may be a rich source with which to counteract diseased networks.

RESULTS:

Our literature search identified 642 hits. The final number of papers included was 41. Using sophisticated animal models (transgenic mice, injection of amyloid β fragments or specific chemicals, surgical interventions) conditions have been generated that resemble Alzheimer's disease, vascular dementia, and other types of dementia. Brain tissues (mainly hippocampus and cortex), blood serum, urine, and feces were investigated using metabolomic, proteomic, and transcriptomic methods. In these experimental dementia models, specific signaling networks were reported to be affected: they regulate pathophysiological mechanisms of inflammation, signal processing and transmission, neuroplasticity, vascular function and blood, cellular integrity and metabolism as well as cellular redox balance. About two dozen polyherbal formulations (mainly derived from traditional Chinese medicine) were used for treatment in these models and partially or fully restored not only the diseased networks (diseasomes) but also the disease symptoms. Another dozen mono-herbal preparations were used to treat dementia in experimental models, and similar beneficial effects were observed.

CONCLUSION:

The selected 41 papers from the literature provided a good basis for a detailed analysis of the role of network pharmacology in understanding the multimodal modes of action of herbal preparations in neurocognitive disorders. Complex signaling networks add valuable new information to classical pharmacology. The understanding of phytopharmaceuticals' modes of action underpin the necessity to expand the search from classic pharmacological models to complex network interactions.

2025-01-01·PHYTOMEDICINE

Ginkgo biloba extract EGb 761® ameliorates cognitive impairment and alleviates TNFα response in 5xFAD Alzheimer‘s disease model mice

Article

作者: Guilherme, Malena Dos Santos ; Slotos, Robert Subirana ; Weisenburger, Sabrina ; Nguyen, Tinh Thi ; Endres, Kristina ; Nguyen, Vu Thu Thuy ; Lehner, Martin D

BACKGROUND:

Ginkgo biloba leaf extract EGb 761® has shown clinical efficacy in patients with mild cognitive impairment and dementia. However, the pharmacological action of EGb 761® in Alzheimer's disease (AD) remains unclear and molecular mechanisms targeted in the brain are not completely understood.

HYPOTHESIS/PURPOSE:

We aimed to investigate 1) the potential sex-dependent effects of oral administration of EGb 761® in 5xFAD mice, an AD mouse model, and 2) the underlying microglial subtype responsible for the observed anti-inflammatory effects in the brain.

METHODS:

Eight-week old 5xFAD and wild type mice received EGb 761®-supplemented diet or control diet for eight weeks. The study investigated changes in cognitive function as well as amyloid plaque load, expression of AD-related genes, and anti-inflammatory effects. Moreover, we used organotypic brain slices for confirmation and assessment of concentration-dependency of the observed EGb 761® effects and performed single cell RNA sequencing on the prefrontal cortex of male mice with focus on microglia.

RESULTS:

We demonstrate that EGb 761® treatment improves cognitive function in 5xFAD mice in several behavioral tests. Analysis of the brain tissue from these animals indicated a reduction in amyloid plaque load in the prefrontal cortex (PFC). This brain area was further investigated to assess the molecular changes that occurred following EGb 761® intake. Alterations in the expression of genes related to AD were highly sex-specific with effects on the cholinergic system, the γ-secretase complex, and neuroinflammation. Anti-inflammatory effects of EGb 761® with a particularly pronounced reduction of the TNFα-response could be shown for the PFC but also peripherally in the serum of 5xFAD mice of both sexes. Single-cell RNA sequencing revealed that EGb761® mainly affected disease-associated microglia stage 2 (DAM2), which are thought to have a detrimental role in AD.

CONCLUSIONS:

EGb 761® shows efficacy in the treatment of cognitive deficits in the 5xFAD mouse model via multimodal activity, including sex-specific and sex-unrelated mechanisms including the normalization of neuroinflammatory parameters.

2024-11-01·PLANTA MEDICA

Basic Requirements and Framework Conditions of Real-World Data (RWD) on Herbal Medicinal Products

Review

作者: Reineke, Thorsten ; Francis, Matthew ; Roether, Bernd ; Hoch, Stefan ; Symma, Nico ; Anquez-Traxler, Christelle ; Hölzle, Salome Sophie

Abstract:

Real-world data (RWD) is becoming increasingly relevant for evaluating safety and effectiveness of medicinal products, including non-prescription medicines and herbal medicinal products in particular. In order to use real-world data for regulatory decision-making in the field of herbal medicinal products, it is crucial to have an accurate description the herbal substances and preparations, as herbal medicinal products, in contrast to chemically defined medicinal products, contain a complex mixture of natural compounds. However, it remains challenging to get standardised information on herbal products from current literature. This publication gives a brief overview of necessary information of herbal medicinal products in scientific literature and data sources to ensure high-quality real-world data.

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