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Набор скоро начнётся NCT07393685

Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD

— Наблюдательное Acute Exacerbation of Chronic Obstructive Pulmonary Disease Influenza, Human Virus Diseases

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: Xuanfei Jiangzhuo Decoction, Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil).
Кому может быть актуально
Состояния в реестре: Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Influenza, Human, Virus Diseases. Базовые параметры: от 60 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
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Официальное название

Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study

Обзор

The goal of this observational study is to learn if a traditional Chinese herbal medicine (Xuanfei Jiangzhuo Decoction) works to help older adults recover from a COPD flare-up caused by the flu (influenza virus). The main questions it aims to answer are: Does the herbal medicine help participants feel better and recover faster? Does it lower the chance of getting a second infection from bacteria? Is the herbal medicine safe to use? Researchers will compare participants who choose to take the herbal medicine along with their standard flu treatment (Oseltamivir or Baloxavir) to participants who only take the standard flu treatment (Oseltamivir or Baloxavir). Participants will: Take the herbal medicine (a liquid drink) twice a day for 5 days, or just take their standard flu medicine for 5 days. Visit the clinic 4 times over 28 days for checkups and tests. Provide blood and stool samples to help researchers understand how the medicine affects the body and gut health. Answer simple questions about their cough, breathing, and energy levels.

Вмешательства

  • Препарат Xuanfei Jiangzhuo Decoction
    A traditional Chinese medicine composite formula derived from Maxing Shigan Tang and Shengjiang San. It is administered orally as a liquid decoction, 200 mL per dose, twice daily (morning and evening, 30 minutes after meals) for 5 days.
  • Препарат Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
    Patients receive standard antiviral treatment according to clinical guidelines and physician judgment. Medications include Oseltamivir (e.g., 75 mg twice daily for 5 days) or Baloxavir marboxil (singl

Первичные конечные точки

  • Time to Clinical Remission of AECOPD [Срок оценки: From baseline (Day 0) up to Day 28]
Вторичные конечные точки (6)
  • Time to Defervescence [Срок оценки: From baseline (Day 0) up to Day 14]
  • Time to Alleviation of Individual Symptoms [Срок оценки: From baseline (Day 0) up to Day 28]
  • Change in COPD Assessment Test (CAT) Score [Срок оценки: Baseline (Day 0), Day 5, Day 14, and Day 28]
  • Rate of Secondary Bacterial Infection [Срок оценки: From baseline (Day 0) through Day 28]
  • Frequency of Rescue Medication Use [Срок оценки: Up to Day 28]
  • Time to Next AECOPD Event [Срок оценки: Up to Day 28]

Критерии участия

Критерии включения

  • Diagnosed with Influenza-induced AECOPD according to the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD 2025) and the Expert Consensus on the Diagnosis and Treatment of AECOPD in China (Updated 2023), confirmed by spirometry and viral testing (antigen or PCR), and excluding pneumonia and heart failure via chest CT and NT-proBNP.
  • Aged 60 years or older.
  • Voluntarily participate and provide written informed consent..

Критерии исключения

  • Known allergy or hypersensitivity to any component of the study medications.
  • Presence of severe bacterial co-infection at enrollment requiring systemic antibiotic therapy.
  • Severe dysfunction of major organs that may interfere with efficacy or safety assessment (e.g., severe cardiac insufficiency, hepatic impairment, or renal failure).
  • Participation in other interventional clinical trials within the past 3 months.
  • Inability to be contacted for follow-up (e.g., lack of permanent address or valid contact information).
  • Any other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation (e.g., severe cognitive impairment or psychiatric disorders).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07393685 · IRB2025-YX-643-01 · IRB2025-YX-643-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗