Lung impotence (Idiopathic pulmonary fibrosis)
Conditions
Interventions
Control group:Placebo TCM granules
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age 40-85 years old, gender is not limited; 2.It meets IPF diagnostic criteria; 3.TCM syndrome classification of lung deficiency and collateral stasis syndrome standard; 4.Did not participate in any other interventional trials within 1 month prior to enrollment; 5.Sign informed consent.
Exclusion criteria
Exclusion criteria: 1.There is significant evidence of obstructive pulmonary disease: forced expiratory volume in the first second (FEV1) /FVC<0.70 or a CT showing a greater degree of emphysema than fibrosis; 2.Lower respiratory tract infections developed within 4 weeks prior to baseline and/or during screening requiring antibiotic or inhaled glucocorticoid therapy; 3.A current history of any malignancy, any malignancy that may result in death or require significant medical or surgical intervention within the next 1 year; 4.In acute exacerbation or late critical condition; 5.Associated with other primary lung diseases (e.g. bronchial asthma, chronic obstructive pulmonary disease, lung cancer); 6.Patients with serious primary diseases of cardiovascular, kidney, liver and other organs; 7.Patients with acute symptoms such as bleeding and fever; 8.Pregnant or lactating women or patients with recent pregnancy plans; 9.Known allergy to the ingredients of the investigational drug; 10.Those deemed not to be included by the investigator: Reasons include inability to comply with study procedures and treatment, addiction, or any other related medical or mental illness; 11.Distinguished from other forms of chronic progressive pulmonary fibrosis: autoimmune diseases in which the lungs are involved, especially interstitial lung disease associated with rheumatoid arthritis or other types of connective tissue disease (CTD), drug-induced pneumonia, pneumoconiosis, chronic HP, chronic sarcoidosis, and rare infections (e.g. tuberculosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbation of pulmonary fibrosis(AE-IPF);The six-minute walk test(6MWT); | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome integral(TCMSS);Lung high resolution CT (HRCT) quantitative integration;Percentage of survival without disease progression;Lung function;Health-related quality of life(HRQoL);Arterial blood gas analysis;modified Medical Research Council Score;Emergency drug use rate; | — |
Countries
China
Contacts
Public ContactLv Xiaodong PangLijian
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed