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Набор скоро начнётся NCT07162870

Idiopathic Pulmonary Fibrosis Cohort of TCM

Наблюдательное Idiopathic Pulmonary Fibrosis (IPF)

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), Non-traditional Chinese medicine (non-TCM).
Кому может быть актуально
Состояния в реестре: Idiopathic Pulmonary Fibrosis (IPF). Базовые параметры: от 40 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 →
Официальное название

Idiopathic Pulmonary Fibrosis Cohort Studies of Chinese Medicine

Обзор

This study, based on past registration records, evaluates the clinical efficacy of traditional Chinese medicine in treating IPF in the real world, identifies advantageous populations and clinical targets, and provides references for precision traditional Chinese medicine treatment.

Подробное описание

This study is based on a previously established registry of interstitial lung disease, with traditional Chinese medicine treatment as the exposure factor. A total of at least 1000 IPF patients will be continuously enrolled and followed up for 2 years; it will further observe the pattern of syndromes, disease characteristics, and their interrelationships during disease development, and evaluate the clinical efficacy of traditional Chinese medicine in treating IPF using indicators such as annual acute exacerbation rate and clinical symptoms. Based on the differences in efficacy indicators, it will identify the advantageous population, clarify the clinical efficacy advantage targets, and provide a basis for precision treatment with traditional Chinese medicine.

Вмешательства

  • Препарат Traditional Chinese medicine (TCM)
    Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure is defined as taking the medication continuously for more than 3 months per year, or intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group is divided into an exposed group (TCM cohort) and an unexposed group (non-TCM cohort).
  • Препарат Non-traditional Chinese medicine (non-TCM)
    All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.

Первичные конечные точки

  • Annual acute exacerbation rate [Срок оценки: Up to week 104]
Вторичные конечные точки (12)
  • Progression-Free Survival(PFS) [Срок оценки: Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
  • All-cause mortality rate [Срок оценки: Up to week 104.]
  • Lung transplantation rate [Срок оценки: Up to week 104.]
  • The Traditional Chinese Medicine(TCM) Syndromes [Срок оценки: Evaluate the TCM s]yndromes at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
  • Clinical symptoms and Signs [Срок оценки: Evaluate the clinical symptoms and signs up at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
  • Forced vital capacity (FVC) [Срок оценки: Evaluate the FVC at baseline and at weeks 26, 52, 78 and 104.]
  • FVC as the percentage of the predicted value (FVC%) [Срок оценки: Evaluate the FVC% at baseline and at weeks 26, 52, 78 and 104.]
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) [Срок оценки: Evaluate the DLCO at baseline and at weeks 26, 52, 78 and 104.]
  • DLCO as the percentage of the predicted value (DLCO%) [Срок оценки: Evaluate the DLCO% at baseline and at weeks 26, 52, 78 and 104.]
  • 6 Six Minute Walk Distance(6MWD) [Срок оценки: Evaluate the 6MWD at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
  • The 30 - second sit - to - stand test(30s STS) [Срок оценки: Evaluate the 30s STS at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
  • A Tool to Assess Quality of life (ATAQ-IPF) total scores [Срок оценки: Evaluate the ATAQ-IPF total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]

Критерии участия

Критерии включения

  • Patients diagnosed with IPF;
  • Age ≥ 40 years old;
  • Voluntary participation in this study,And sign the informed consent form.

Критерии исключения

  • Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
  • Patients who are unable to take care of themselves and have been bedridden for a long time.

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
  • The First Affiliated Hospital of Henan University of Chinese Medicine — Чжэнчжоу

Идентификаторы

NCT: NCT07162870 · Cohort of IPF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗