Clinical trial NCT06577753: REspiratory diSEAse cohoRt Studies of CHinese Medicine for ILD (RESEARCH-ILD)
Official title: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Interstitial Lung Disease (RESEARCH-ILD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
Traditional Chinese Medicine
Cohort study
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interstitial lung disease (ILD) is a group of lung diseases characterized by inflammation and/or fibrosis of the lung parenchyma, often accompanied by progressive respiratory distress, which may ultimately lead to end-stage respiratory failure.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who meet the diagnosis of ILD;
2. Age≥18 years old;
3. Ability to provide independent informed consent.

Exclusion Criteria:

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.
measure: Lung transplantation
timeFrame: Up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.
Secondary outcomes:
measure: Frequencies of acute exacerbations (AEs)
timeFrame: The frequencies of acute exacerbations at weeks 13, 26, 39, 52, 65, 78, 91 and 104.
measure: Proportion of progressive-free survival
timeFrame: The Proportion of progressive-free survival at weeks 13, 26, 39, 52, 65, 78, 91 and 104.
measure: 6 Six Minute Walk Distance(6MWD)
timeFrame: Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: Pulse Oxygen Saturation（SPO2）
timeFrame: Change from baseline SPO2 at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: Traditional Chinese medicine syndromes
timeFrame: The traditional Chinese medicine syndromes at weeks 13, 26, 39, 52, 65, 78 ,91 and 104.s.
measure: Clinical symptoms and Signs
timeFrame: Change from baseline clinical symptoms and signs up at week 13, 26, 39, 52, 65, 78, 91 and 104 weeks.
measure: Pulmonary function
timeFrame: Change from baseline FVC, FVC%, DLco and DLco% at week 26, 52, 78 and 104.
measure: St. George's respiratory questionnaire (SGRQ) total scores
timeFrame: Change from baseline SGRQ total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: A Tool to Assess Quality of life in IPF(ATAQ-IPF) total scores
timeFrame: Change from baseline ATAQ-IPF total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: Imaging findings
timeFrame: Change from baseline Imaging findings at week 13, 26, 39, 52, 65, 78, 91 and 104.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jian-sheng Li, Professor
role: STUDY_CHAIR
References: