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Набор скоро начнётся NCT07286110

Chinese Herbal Therapy (Qiqi Shengmai Formula) for Moyamoya Vasculopathy: The CHIMES Trial

Фаза I С лечением Moyamoya Disease Moyamoya Syndrome

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: Traditional Chinese Medicine (TCM) Treatment, Conventional medical treatment, TCM Placebo.
Кому может быть актуально
Состояния в реестре: Moyamoya Disease, Moyamoya Syndrome. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Chinese Herbal Intervention (Qiqi Shengmai Formula) for Moyamoya Vasculopathy in Cerebral Hemodynamics (CHIMES ): a Single-center, Prospective, Randomized Controlled Study

Обзор

Patients diagnosed with moyamoya vasculopathy by imaging and classified as having the Traditional Chinese Medicine (TCM) syndrome of liver-yang hyperactivity will be enrolled. On the basis of standardized Western medical management, participants will receive the standardized TCM herbal formula "Qiqi Shengmai Formula" (comprising Astragali Radix, Rehmanniae Radix Praeparata, Schisandrae Fructus, Bupleuri Radix, Paeoniae Radix Alba, and Notoginseng Radix). Structured follow-up will be conducted. By comparing endpoint indicators across different treatment regimens, the study aims to evaluate the efficacy of integrated TCM-Western medicine therapy for moyamoya vasculopathy and to generate evidence-based support for an integrated diagnostic and therapeutic model.

Вмешательства

  • Препарат Traditional Chinese Medicine (TCM) Treatment
    Patients receive the standardized TCM formula Qiqi Shengmai Decoction (composed of Astragali Radix, Rehmanniae Radix Praeparata, Schisandrae Fructus, Bupleuri Radix, Paeoniae Radix Alba, and Notoginseng Radix). The prescription is taken twice daily, one dose per administration, for six consecutive weeks, with each dose consumed 30 minutes after breakfast and dinner
  • Препарат Conventional medical treatment
    For ischemic-type moyamoya disease, antiplatelet monotherapy with cilostazol is administered, while antiplatelet therapy is not recommended for asymptomatic patients or those with hemorrhagic-type moyamoya disease. For patients with concomitant dyslipidemia, statins and evolocumab may be added, with low-density lipoprotein cholesterol controlled to 70 mg/dL (1.8 mmol/L). Blood pressure is maintained at 140/90 mmHg, and glycemic management targets a hemoglobin A1c level of \<7.0%.
  • Препарат TCM Placebo
    The placebo consists primarily of medicinal starch, food-grade caramel coloring (for color correction), and a bittering agent (for flavor adjustment). Its appearance-including shape, size, color, and taste-is identical to that of the herbal preparation. It is administered twice daily, one dose at each administration, for six consecutive weeks, taken 30 minutes after breakfast and dinner.

Первичные конечные точки

  • CT Perfusion [Срок оценки: Baseline, at 3 months, 6 months, and 12 months after enrollment]
Вторичные конечные точки (7)
  • Digital Subtraction Angiography [Срок оценки: Baseline, 12 months after enrollment]
  • Integrated Head-Neck High-Resolution Vessel Wall MRI [Срок оценки: Baseline, 6 months, and 12 months after enrollment]
  • TCM Symptom Scale [Срок оценки: Baseline, at 3 months, 6 months, and 12 months after enrollment]
  • Modified Rankin Scale (mRS) [Срок оценки: Baseline, at 3 month, 6 months, and 12 months after enrollment]
  • TCM Constitution Classification [Срок оценки: Baseline, at 3 month, 6 month, and 12 months after enrollment]
  • Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, and at 3, 6, and 12 months after enrollment]
  • National Institutes of Health Stroke Scale (NIHSS) [Срок оценки: Baseline and at 3, 6, and 12 months after enrollment]

Критерии участия

Критерии включения

  • Imaging findings meeting the Western medical diagnostic criteria for moyamoya vasculopathy
  • Age between 18 and 80 years
  • The patient and family members are fully informed and voluntarily consent to participation, with the informed consent process conducted in accordance with GCP requirements
  • Willingness to receive Traditional Chinese Medicine treatment
  • Traditional Chinese Medicine syndrome differentiation consistent with liver-yang hyperactivity

Критерии исключения

  • Acute cerebrovascular events within the preceding 6 weeks
  • Known allergy to contrast agents or to the investigational medication
  • Presence of severe primary diseases involving the cardiac, pulmonary, hepatic, renal, endocrine, or hematopoietic systems
  • Pregnant or breastfeeding women
  • Patients scheduled to undergo cerebral revascularization surgery
  • Participation in other ongoing clinical trial

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

Китай · 1 центр
  • 180 Fenglin Road, Xuhui District, Shanghai 200032,China — Шанхай

Идентификаторы

NCT: NCT07286110 · ShanghaiZhongshan

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗