Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic Stroke

Официальное название

Efficacy and Safety of Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Patients With Acute Ischemic Stroke : A Randomized Double-blind Placebo-controlled Pilot Trial

Обзор

The purpose of this study is to assess the effectiveness and safety of Qingre Huatan formula versus placebo on preventing early neurological deterioration in patients with acute ischemic stroke within 48 hours after onset.

Вмешательства

• Препарат Qingre Huatan Formula
  Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
• Препарат Qingre Huatan Formula placebo
  Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.
• Другое Guidelines-based standard care
  Guidelines-based standard care for acute ischemic stroke

Первичные конечные точки

• The incidence of early neurological deterioration within 7 days of onset [Срок оценки: Basline and Day 7]

Вторичные конечные точки (6)

• Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment) [Срок оценки: Basline and 10 days after treatment initiation]
• The proportion of patients with modified Rankin Scale score ≤2 on day 30 [Срок оценки: Day 30]
• The proportion of patients with modified Rankin Scale score ≤2 on day 90 [Срок оценки: Day 90]
• Activity of daily living of patients measured by Barthel Index score on day 30 [Срок оценки: Day 30]
• Activity of daily living of patients measured by Barthel Index score on day 90 [Срок оценки: Day 90]
• Incidence of treatment-related adverse events [Срок оценки: 90 days after treatment initiation]

Критерии участия

Критерии включения

• Inpatients diagnosed with acute ischemic stroke. Inpatients diagnosed of acute ischemic stroke.
• Meet the criteria of TCM phlegm-heat syndrome
• Patients at high-risk of END : Magnetic resonance imaging (MRI) reveals new ischemic lesions, with DWI-ASPECTS score ≤ 7, or presence of at least two risk factors of END.
• Acute ischemic stroke within 48 hours after onset.
• Aged 18-80 years, male or female.
• The patient or representative has signed informed consent.

Критерии исключения

• Received or planned thrombolysis or endovascular therapy after onset.
• Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
• Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
• Diseases that cause motor dysfunction, including osteoarthritis, etc.
• Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase > 2 times the upper limit of normal value, serum creatinine > 1.5 times the upper limit of normal value)
• Known severe aphasia or mental illness affecting clinical information collection and evaluation.
• Pregnancy, potential pregnancy or breastfeeding.
• Currently participating in other clinical trials.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Dongzhimen Hospital — Пекин

Публикации

• Zheng X, Yang Z, Wu H, Zhao M, Que C, Xiong X, Mu Y, Zhang G, Kang L, Gao Y, Lai X. Efficacy and safety of Qingre Huatan Formula for the prevention of early neurological deterioration in patients with acute ischemic stroke (QUIET): rationale and design for a randomized double-blind placebo-controlled study. Front Med (Lausanne). 2026 Apr 13;13:1754648. doi: 10.3389/fmed.2026.1754648. eCollection 2 PMID 42051694

Идентификаторы

NCT: NCT06857487 · 2023DZMEC-410-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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