Pulmonary fibrosis
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Henan University of CM
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with PPF;2.Aged 18 or older;3.Comply with TCM syndrome differentiation standards;4.Not participate in any other drug trial within one month prior to enrollment;5.FEV1/FVC=70% before bronchodilator use;6.FVC% predicted =45%;7.Dlco% predicted corrected for normal hemoglobin (Hb) normal = 30%–< 80%;8.Sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with IPF;2.patients with confused,dementia,various mentally ill people and cannot communicate normally;3.Paitients with acute exacerbation of PPF ;4.Major extra-pulmonary physiologic limitation(eg chest wall abnormalities,massive of pleural effusion);5.Tumor before screening (except localized cancer such as basal cell carcinoma)within 5 year;6.Unstable or worsening heart disease within 6 months prior to screening,including but not limited to the following:myocardial infarction;unstable angina;congestive heart failure (requiring treatment in hospital or NYHA III/IV);uncontrolled severe cardiac arrhythmia;7.TBIL>1.2×ULN,AST or ALT>1.5×ULN;8.CLcr20mg/ day,and OCS+AZA+NAC;cyclophosphamide within 8 weeks prior to randomization;Rituximab within 6 months prior to randomization;10.Unable to complete PFT,6MWT,or questionnaire;11.Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual decline rate of FVC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual acute exacerbations;6MWT;Quality of life;Progression-free survival;Severity of dyspnea;Health-related quality of life;Clinical symptoms;All cause mortality; | — |
Countries
China
Contacts
Public ContactLi Jiansheng
Outcome results
None listed