REspiratory diSEAse cohoRt Studies of CHinese Medicine for ILD (RESEARCH-ILD)
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Interstitial Lung Disease. Базовые параметры: от 18 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
REspiratory diSEAse cohoRt Studies of CHinese Medicine for Interstitial Lung Disease (RESEARCH-ILD)
Обзор
This study is a traditional Chinese medicine cohort for interstitial lung disease（ILD） in China, including at least 5000 patients with ILD and followed up for at least 5 years. The aim is to focus on the demographic characteristics, clinical features, disease occurrence and development characteristics, TCM syndrome evolution patterns, and clinical efficacy of TCM treatment for ILD in the real world.
Подробное описание
This study focuses on ILD patients and adopts a prospective cohort study design, with traditional Chinese medicine treatment as the exposure factor. The subjects are divided into a traditional Chinese medicine cohort and a non traditional Chinese medicine cohort, with demographic characteristics, mortality rate, lung transplant rate, annual acute exacerbation frequency, traditional Chinese medicine syndrome, 6MWT, lung function, dyspnea score, quality of life, and other observation indicators. Follow up for at least 5 years will be conducted, and at least 5000 ILD patients will be included, focusing on the demographic characteristics, clinical characteristics, disease occurrence and development characteristics, traditional Chinese medicine syndrome evolution rules, and clinical efficacy of traditional Chinese medicine treatment for ILD in the real world.
Первичные конечные точки
- All-cause mortality [Срок оценки: up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.]
- Lung transplantation [Срок оценки: Up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.]
Вторичные конечные точки (10)
- Frequencies of acute exacerbations (AEs) [Срок оценки: The frequencies of acute exacerbations at weeks 13, 26, 39, 52, 65, 78, 91 and 104.]
- Proportion of progressive-free survival [Срок оценки: The Proportion of progressive-free survival at weeks 13, 26, 39, 52, 65, 78, 91 and 104.]
- 6 Six Minute Walk Distance(6MWD) [Срок оценки: Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.]
- Pulse Oxygen Saturation（SPO2） [Срок оценки: Change from baseline SPO2 at week 13, 26, 39, 52, 65, 78, 91 and 104.]
- Traditional Chinese medicine syndromes [Срок оценки: The traditional Chinese medicine syndromes at weeks 13, 26, 39, 52, 65, 78 ,91 and 104.s.]
- Clinical symptoms and Signs [Срок оценки: Change from baseline clinical symptoms and signs up at week 13, 26, 39, 52, 65, 78, 91 and 104 weeks.]
- Pulmonary function [Срок оценки: Change from baseline FVC, FVC%, DLco and DLco% at week 26, 52, 78 and 104.]
- St. George's respiratory questionnaire (SGRQ) total scores [Срок оценки: Change from baseline SGRQ total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.]
- A Tool to Assess Quality of life in IPF(ATAQ-IPF) total scores [Срок оценки: Change from baseline ATAQ-IPF total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.]
- Imaging findings [Срок оценки: Change from baseline Imaging findings at week 13, 26, 39, 52, 65, 78, 91 and 104.]
Критерии участия
Критерии включения
- Patients who meet the diagnosis of ILD;
- Age≥18 years old;
- Ability to provide independent informed consent.
Критерии исключения
Patients with acute ILD caused by known reasons, but the lesions disappear within 2 weeks after treatment. Example: Interstitial pneumonia caused by infections such as mycoplasma/virus, and those who recover after treatment are excluded.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- The First Affiliated Hospital of Henan University of Chinese Medicine — Чжэнчжоу
Идентификаторы
NCT: NCT06577753 · RESEARCH-ILD