An observational study in Idiopathic Pulmonary Fibrosis (IPF), sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Henan University of Traditional Chinese Medicine · Observational
This study, based on previous registration records, aims to explore the syndrome patterns, disease characteristics, and their interrelationships of IPF at different stages, grades, and in its natural course, thus providing a multidimensional interpretation of the syndrome patterns and characteristics of IPF.
This study, based on previous registration records, uses a cross-sectional survey design to collect demographic information, disease-related data, syndrome data, and auxiliary examination data from 2864 IPF patients in China. It aims to elucidate the syndrome types, disease characteristics, and the interrelationships between them of IPF at different stages, grades, and in its natural course.
Idiopathic pulmonary fibrosis (IPF) is a special type of idiopathic interstitial pneumonia, which is mainly manifested by irritating dry cough and progressive dyspnea.
Exclusion Criteria:
Participants fill out the questionnaire
Disease Stage
Recording the disease staging of IPF patients. According to the Adult Idiopathic Pulmonary Fibrosis (Revised Edition) and Progressive Pulmonary Fibrosis: ATS/ERS/JRS/ALAT Official Clinical Practice Guidelines (2022 Edition), and the Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis, the disease staging evaluation of IPF is stable phase or acute exacerbation.
Time frame: Evaluate at baseline.
Gender, age and physiologic variables (GAP)stage
Recording the GAP stage of IPF patients. GAP stage is a risk stratification method that quantifies the three core parameters of patients: gender, age, and physiological parameters, by calculating the total score and conducting risk stratification.
Time frame: Evaluate at baseline.
Pulmonary function classification
Recording the pulmonary function classification of IPF patients. According to The Expert Consensus on the Diagnostic Criteria for Adult Lung Function in China, pulmonary function classification is divided into mild, moderate, and severe grades.
Time frame: Evaluate at baseline.
Natural course
Recording the natural course of IPF patient. According to international research, the natural course of IPF can be divided into stable, slow progression, rapid progression, and recurrent acute exacerbation. The specific criteria are as follows: 1.stable: FVC annual decline\<0.13L; 2. stable slow progression: FVC annual decline 0.13L-0.21L; 3. Rapid progress: FVC annual decline\>0.21L; 4. Recurrent acute exacerbations: Annual number of acute exacerbations ≥ 1.
Time frame: Evaluate at baseline.
The Traditional Chinese Medicine(TCM) Syndromes
Evaluate traditional Chinese medicine syndromes by collecting patients' symptoms, signs, and tongue pulse information.
Time frame: Evaluate at baseline.
6 Six Minute Walk Distance(6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Time frame: Evaluate at baseline.
The 30 - second sit - to - stand test(30s STS)
The 30 second sitting and standing test will be used to evaluate lower limb strength and cardiopulmonary function.
Time frame: Evaluate at baseline.
A Tool to Assess Quality of life (ATAQ-IPF) total scores
ATAQ-IPF is currently a specialized scale for evaluating the quality of life, consisting of 13 dimensions and 74 items, with each item scored on a 1-5 scale. The higher the score, the worse the quality of life.
Time frame: Evaluate at baseline.
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.
Time frame: Evaluate at baseline.
Dyspnea
Dyspnea will be assessed by modified Medical Research Council(mMRC) scores. A score of 0-4 will be givenaccording to the degree of immediate dyspnea. A higher score indicates a worse condition.
Time frame: Evaluate at baseline.
C-reactive protein (CRP)
The CRP level will be detected by ELISA technology.
Time frame: Evaluate at baseline.
Krebs Von den Lungen-6（KL-6）
The KL-6 level will be detected by ELISA technology.
Time frame: Evaluate at baseline.
The pulmonary artery systolic pressure(PASP)
The PASP will be measured byechocardiogram.
Time frame: Evaluate at baseline.
The diameter of the pulmonary artery
The diameter of the pulmonary artery will be measured byechocardiogram.
Time frame: Evaluate at baseline.
Forced vital capacity (FVC)
FVC will be applied to assess pulmonary function.
Time frame: Evaluate at baseline.
FVC as the percentage of the predicted value (FVC%)
FVC% will be applied to assess pulmonary function.
Time frame: Evaluate at baseline.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
DLCO will be applied to assess pulmonary function.
Time frame: Evaluate at baseline.
DLCO as the percentage of the predicted value (DLCO%)
DLCO% will be applied to assess pulmonary function.
Time frame: Evaluate at baseline.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis→
Henan University of Traditional Chinese Medicine