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Набор скоро начнётся NCT07690020

Clinical Efficacy and Mechanism Research of Getong Tongluo Capsule in Ischemic Stroke

Без фазы С лечением Ischemic Stroke, Acute

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Getong Tongluo Capsule, Matched Starch Placebo Capsule, Standard Routine Therapy for Ischemic Stroke.
Кому может быть актуально
Состояния в реестре: Ischemic Stroke, Acute. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this single-center, randomized, double-blind, controlled trial is to clarify the clinical efficacy and safety of Getong Tongluo Capsule in patients with ischemic stroke. Combined with gut microbiome and metabolomics techniques, investigators will explore whether this medicine exerts neuroprotective effects via the gut-brain axis. Investigators will further verify its pharmacological mechanism through animal experiments to provide evidence for its clinical application.

Вмешательства

  • Препарат Getong Tongluo Capsule
    Oral proprietary Chinese medicine for convalescent ischemic stroke. Subjects take 2 capsules (0.25 g each), twice daily, on top of guideline-standardized antiplatelet, lipid-lowering, antihypertensive and hypoglycemic routine stroke treatment. Treatment period ranges from 14±7 days to 6 months after stroke onset.
  • Другое Matched Starch Placebo Capsule
    Starch-filled blank capsules identical to Getong Tongluo Capsule in appearance, size and taste. Subjects take 2 capsules (0.25 g each), twice daily together with standardized basic stroke therapy, for 14±7 days to 6 months post stroke.
  • Препарат Standard Routine Therapy for Ischemic Stroke
    Individualized guideline-directed basic stroke care including antiplatelet, lipid-regulating, blood pressure and glucose lowering medications, provided to all participants in both treatment and placebo arms throughout the study.

Первичные конечные точки

  • Distribution of modified Rankin Scale (mRS) scores [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • Incidence of adverse events [Срок оценки: Through study completion, an average of 6 months]
Вторичные конечные точки (8)
  • Athens Insomnia Scale (AIS) score [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • Proportion of Traditional Chinese Medicine(TCM) Syndrome Improvement [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • Activities of Daily Living (ADL) score [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • Hamilton Depression Rating Scale (HAMD) score [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • Hamilton Anxiety Rating Scale (HAMA) score [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • Montreal Cognitive Assessment (MoCA) score [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • MMSE score [Срок оценки: Baseline, 3-month follow-up and 6-month follow-up]
  • Incidence rate of drug-related adverse reactions [Срок оценки: Through study completion, an average of 6 months]

Критерии участия

Критерии включения

  • Voluntarily sign the informed consent form
  • Aged between 18 and 80 years old
  • Conform to the diagnosis of acute ischemic stroke referring to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)
  • Hospital admission within 21 days after disease onset

Критерии исключения

  • Patients with mild or no neurological deficits on admission: those with a score of 0 on the Modified Rankin Scale (mRS) at admission (defined as completely asymptomatic).
  • Patients with severe baseline disability: those with a pre-stroke mRS score ≥ 3 (indicating moderate to severe disability requiring partial or full assistance with activities of daily living).
  • Patients with transient ischemic attack, concomitant cerebral hemorrhage or subarachnoid hemorrhage; those complicated with brain tumor, Alzheimer's disease, psychiatric disorders, or suspected pre-stroke cognitive dysfunction.
  • Patients complicated with severe cardiac diseases including valvular heart disease, infective endocarditis, myocardial infarction and heart failure; severe hepatic or renal insufficiency, respiratory failure, malignant tumors, or massive gastrointestinal hemorrhage.
  • Patients who received any preparations containing the same active ingredients as the study drug (e.g., Pueraria lobata) within 2 weeks prior to stroke onset.
  • Patients with a history of allergy to the study drug or preparations with identical active ingredients.
  • Patients who received antibiotics within 1 month before onset; those taking probiotics or prebiotics long-term; patients with a past or in-hospital confirmed gastrointestinal disease history.
  • Pregnant and lactating women.
  • Patients deemed unsuitable for participation in this trial at the investigator's discretion.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07690020 · NFEC-2026-409

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗