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Набор скоро начнётся NCT06933238

Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis

Фаза I / Фаза II С лечением Sepsis Abdominal Gastrointestinal Dysfunction Traditional Chinese Medicine

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: Fuzheng Tongfu Jiedu prescription (FZTFJD), Placebo.
Кому может быть актуально
Состояния в реестре: Sepsis Abdominal, Gastrointestinal Dysfunction, Traditional Chinese Medicine. Базовые параметры: 50 лет — 90 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

The Clinical Effect and Mechanism of Fuzheng Tongfu Jiedu Prescription Regulating Cell Pyrodeath in the Treatment of Gastrointestinal Dysfunction in Sepsis Based on mtDNA/NLRP3/Caspase-1/GSDMD Signaling Pathway

Обзор

This study is a single-center, randomized, double-blind, placebo-controlled trial.

Подробное описание

The study is designed to evaluate efficacy and safety of FZTFJD for treating gastrointestinal dysfunction associated with sepsis compared to placebo in combination with conventional western medicine treatment. Participants included in this study are diagnosed with sepsis-induced gastrointestinal dysfunction classified as Acute gastrointestinal injury (AGI)grades I-III. A total of seventy patients will be randomly assigned in a 1:1 ratio to receive either FZTFJD or placebo. The study encompasses a treatment duration of seven days followed by a twenty-one-day safety follow-up period. The AGI grade as the primary outcome measure will be assessed, while gut symptom score, abdominal pressure and circumference, SOFA and APACHE II scores, inflammation level as well as intestinal barrier function will serve as secondary outcome measures. Additionally, length of ICU stay and 28-day mortality will be included as prognostic indicators in this study.

Вмешательства

  • Препарат Fuzheng Tongfu Jiedu prescription (FZTFJD)
    Fuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.
  • Препарат Placebo
    Fuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.

Первичные конечные точки

  • AGI grade [Срок оценки: Day0, Day3,Day7,Day14]
Вторичные конечные точки (12)
  • Gastrointestinal symptoms score [Срок оценки: Day0, Day3,Day7,Day14]
  • Abdominal pressure [Срок оценки: Day0, Day3,Day7,Day14]
  • Abdominal circumference [Срок оценки: Day0, Day3,Day7,Day14]
  • Blood routine [Срок оценки: Day0, Day3,Day7,Day14]
  • CRP [Срок оценки: Day0, Day3,Day7,Day14]
  • PCT [Срок оценки: Day0, Day3,Day7,Day14]
  • Immune index-T cell functional subsets [Срок оценки: Day0,Day7]
  • Immune index-lymphocyte subsets [Срок оценки: Day0, Day7]
  • Intestinal barrier function-diamine oxidase（DAO） [Срок оценки: Day0, Day7]
  • Intestinal barrier function-D-lactic acid level [Срок оценки: Day0, Day7]
  • Intestinal barrier function--intestinal type Fatty acid Binding Protein (FABP) [Срок оценки: Day0、 Day7]
  • Intestinal barrier function-Citrulline (CIT) [Срок оценки: Day0、 Day7]

Критерии участия

Критерии включения

  • Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
  • 50-90 years old, regardless of gender.
  • Sequential Organ Failure Assessment (SOFA) score ≥ 2.
  • Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
  • Voluntary participation with signed informed consent.

Критерии исключения

  • ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
  • Patients with allergies or allergic constitution to the investigational herbal medications.
  • Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight > 150 kg), trauma, or surgical factors.
  • Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
  • History of gastrointestinal surgery.
  • Long-term use of corticosteroids or immunosuppressants.
  • Severe psychiatric disorders or inability to cooperate with trial protocols.
  • Participation in other clinical trials within 30 days.
  • Pregnant or lactating women.
  • Participated in other clinical studies in the past 3 months.

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
  • Ethics Committee of Dongzhimen Hospital — Пекин

Идентификаторы

NCT: NCT06933238 · DZMG-QNZX-24008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗