REspiratory diSEAse cohoRt Studies of CHinese Medicine for ILD (RESEARCH-ILD)
NCT Number: NCT06577753
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Interstitial Lung Disease
Sponsor: Henan University of Traditional Chinese Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-15
Completion Date: 2030-12-30
Locations: The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China

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.

Primary Outcome Measures: All-cause mortality, The all-cause mortality will be recorded., up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.|Lung transplantation, The lung transplantation will be calculated in each cohort at the end of the trial., Up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.
Secondary Outcome Measures: Frequencies of acute exacerbations (AEs), The frequencies of acute exacerbations (AEs) will be recorded. The diagnostic criteria for acute exacerbation refer to the 2016 international consensus and the 2019 Chinese expert consensus., The frequencies of acute exacerbations at weeks 13, 26, 39, 52, 65, 78, 91 and 104.|Proportion of progressive-free survival, The Proportion of progressive-free survival will be recorded.The disease progression criteria refer to the relevant provisions of the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelinefor PPF, including deterioration of respiratory symptoms, physiological evidence of disease progression, and radiological evidence., The Proportion of progressive-free survival at weeks 13, 26, 39, 52, 65, 78, 91 and 104.|6 Six Minute Walk Distance(6MWD), 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity., Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.|Pulse Oxygen Saturation（SPO2）, Before and after the 6-minute walk test, blood oxygen saturation (SPO2) will be detected through a pulse oximeter monitor., Change from baseline SPO2 at week 13, 26, 39, 52, 65, 78, 91 and 104.|Traditional Chinese medicine syndromes, The Traditional Chinese medicine syndromes will be recorded. The diagnosis of traditional Chinese medicine syndromes for IPF refers to the 2019 version of the diagnostic criteria for idiopathic pulmonary fibrosis, while PPF refers to the 2012 version of the diagnostic criteria for diffuse interstitial lung disease., The traditional Chinese medicine syndromes at weeks 13, 26, 39, 52, 65, 78 ,91 and 104.s.|Clinical symptoms and Signs, Clinical symptoms and Signs will be evaluated through a scale. The scale includes coughing, expectoration, chest tightness, shortness of breath, wheezin. The Clinical Symptom Rating Scale includes 6 items: cough, expectoration, chest tightness, shortness of breath, wheezing, and cyanosis. Each item has a score of 0-3, totaling 18 points. The higher the score, the worse he patient's condition., Change from baseline clinical symptoms and signs up at week 13, 26, 39, 52, 65, 78, 91 and 104 weeks.|Pulmonary function, Forced vital capacity (FVC), FVC as the percentage of the predicted value（FVC%）, carbon monoxide diffusing capacity（DLco）and DLco as the percentage of the predicted value (DLco%) will be applied to assess pulmonary function., Change from baseline FVC, FVC%, DLco and DLco% at week 26, 52, 78 and 104.|St. George's respiratory questionnaire (SGRQ) total scores, SGRQ is a scale used to evaluate the quality of life of patients, which includes three dimensions: symptoms, mobility, and the impact of disease on daily life, with a total of 50 items. The total score range of SGRQ is usually between 0 and 100, with higher scores leading to poorer quality of life., 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, ATAQ-IPF is currently a specialized scale for evaluating the quality of life of IPF patients, consisting of 13 dimensions and 74 items, with each item scoring 1-5 points. The higher the score, the worse the quality of life., Change from baseline ATAQ-IPF total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.|Imaging findings, The Imaging findings will be recorded by HRCT examination., Change from baseline Imaging findings at week 13, 26, 39, 52, 65, 78, 91 and 104.