Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke

Официальное название

Effect of Ginkgo Biloba Extract on Cognitive Function in Acute Ischemic Stroke: a Multicentre, Randomised, Open-label, Blinded-Endpoint Trial

Обзор

The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.

Подробное описание

Vascular brain injury is a common post-stroke complication that can reduce cognitive function and lead to vascular cognitive impairment, placing a significant burden on families and society. The purpose of this study is to determine the effect of ginkgo biloba extract on cognitive function in acute ischemic stroke.

Вмешательства

• Препарат Ginkgo Biloba Extract
  Ginkgo biloba extract 8 pills three times per day is administrated.

Первичные конечные точки

• Changes of the Montreal Cognitive Assessment (MoCA) score [Срок оценки: 180 days]

Вторичные конечные точки (4)

• Changes of the Mini-Metal State Examination (MMSE) score [Срок оценки: 180 days]
• the Montreal Cognitive Assessment (MoCA) score [Срок оценки: 180 days]
• the Mini-Metal State Examination (MMSE) score [Срок оценки: 180 days]
• the modified rankin scale (mRS) score [Срок оценки: 90 days; 180 days]

Критерии участия

Критерии включения

• Patients with a definitive clinical diagnosis of acute ischemic stroke;
• Age≥18 years, regardless of sex；
• Primary education level or higher; baseline MoCA score of 10-25 points;
• Able to complete cognitive scale scoring;
• Informed consent is signed and ginkgo biloba extract therapy is initiated within 14 days of onset.

Критерии исключения

• Transient ischemic attack；
• Patients who received emergency reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy) at onset;
• Combined with other neurological diseases, such as neurodegenerative diseases (e.g., Alzheimer's disease, Parkinson's disease, Lewy body dementia, and frontotemporal dementia), optic neuritis, epilepsy, central nervous system infections (e.g., AIDS and syphilis), traumatic brain injury dementia, etc；
• Currently using psychoactive medications (e.g., antidepressants) or anti-epileptic drugs, or if the time since their last use of these medications was less than 5 half-lives (per the pharmacokinetics of each specific medication; for drugs with unknown half-lives, a 1 month washout period was required)；
• Had a pre-existing diagnosis of a cognitive disorder；
• Currently taking medications intended to improve cognitive function or prevent dementia (e.g., cholinesterase inhibitors, memantine, nootropics), or if the washout period since their last use of these medications was less than 5 half-lives as specified in each drug's pharmacokinetics. For drugs with unknown half-lives, a minimum 1 month washout period was required；
• Severe liver and kidney dysfunction;
• Active ulcer or bleeding diathesis；
• Allergy to preparations containing ginkgo biloba extract；
• Pregnant or lactating women, patients with a life expectancy less than 6 months, and those unable to complete the study for other reason；
• Unwillingness to be followed up or poor treatment compliance;
• Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment;
• Other conditions that the investigators deemed unsuitable for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06140888 · BEFIT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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