Disease-syndrome Characteristics of IPF
ConditionIdiopathic Pulmonary Fibrosis (IPF)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan University of Traditional Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with IPF;
Age ≥ 18 years old;
Voluntarily participate in this study and sign an informed consent form.
Disqualifiers
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.
Trial population
Idiopathic pulmonary fibrosis (IPF) is a special type of idiopathic interstitial pneumonia, which is mainly manifested by irritating dry cough and progressive dyspnea.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
2,864 Participants
are grouped into 1 trial groupGroup A: Participants fill out the questionnaire
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Henan University of Traditional Chinese Medicine
Lead sponsor
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborator
China-Japan Friendship Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: