The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000, China
Not Yet Recruiting
NCT Number: NCT07178392
Disease-syndrome Characteristics of IPF
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.
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Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients diagnosed with IPF;
- Age ≥ 18 years old;
- Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
- Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
- Those who are unable to take care of themselves and have been bedridden for a long time.
Treatment and study plan
Primary outcomes
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Disease Stage
Time frame: Evaluate at baseline.
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.
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Gender, age and physiologic variables (GAP)stage
Time frame: Evaluate at baseline.
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.
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Pulmonary function classification
Time frame: Evaluate at baseline.
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.
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Natural course
Time frame: Evaluate at baseline.
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.
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The Traditional Chinese Medicine(TCM) Syndromes
Time frame: Evaluate at baseline.
Evaluate traditional Chinese medicine syndromes by collecting patients' symptoms, signs, and tongue pulse information.
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6 Six Minute Walk Distance(6MWD)
Time frame: Evaluate at baseline.
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
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The 30 - second sit - to - stand test(30s STS)
Time frame: Evaluate at baseline.
The 30 second sitting and standing test will be used to evaluate lower limb strength and cardiopulmonary function.
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A Tool to Assess Quality of life (ATAQ-IPF) total scores
Time frame: Evaluate at baseline.
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.
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St. George's respiratory questionnaire (SGRQ) total scores
Time frame: Evaluate at baseline.
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.
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Dyspnea
Time frame: Evaluate at baseline.
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.
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C-reactive protein (CRP)
Time frame: Evaluate at baseline.
The CRP level will be detected by ELISA technology.
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Krebs Von den Lungen-6（KL-6）
Time frame: Evaluate at baseline.
The KL-6 level will be detected by ELISA technology.
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The pulmonary artery systolic pressure(PASP)
Time frame: Evaluate at baseline.
The PASP will be measured byechocardiogram.
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The diameter of the pulmonary artery
Time frame: Evaluate at baseline.
The diameter of the pulmonary artery will be measured byechocardiogram.
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Forced vital capacity (FVC)
Time frame: Evaluate at baseline.
FVC will be applied to assess pulmonary function.
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FVC as the percentage of the predicted value (FVC%)
Time frame: Evaluate at baseline.
FVC% will be applied to assess pulmonary function.
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Diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: Evaluate at baseline.
DLCO will be applied to assess pulmonary function.
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DLCO as the percentage of the predicted value (DLCO%)
Time frame: Evaluate at baseline.
DLCO% will be applied to assess pulmonary function.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Henan University of Traditional Chinese Medicine
Other
Collaborators
- China-Japan Friendship Hospital
- Shanghai Pulmonary Hospital, Shanghai, China
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
- The First Affiliated Hospital of Zhengzhou University
Registry information
Official study title
Research on the Disease-syndrome Characteristics of Idiopathic Pulmonary Fibrosis
Important dates
- Study start
- 2025
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Sep 17, 2025
- Registry last updated
- Sep 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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