Progressive Pulmonary Fibrosis
Conditions
Interventions
Treatment group:Sancai Huanxian Formula + conventional Western medicine treatment
Control group:conventional Western medicine treatment
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years and <80 years, no gender restriction; (2) Diagnosed with interstitial lung disease (ILD) and meeting the definition of PPF according to the ATS/ERS/JRS/ALAT Clinical Practice Guideline; (3) Meeting the Traditional Chinese Medicine diagnostic criteria for the pattern of "dual deficiency of qi and yin complicated by phlegm-stasis obstruction"; (4) Forced vital capacity: at screening visit, FVC%Pred =30%; (5) Diffusing capacity of the lungs for carbon monoxide: at screening visit, DLCO%Pred =30% (corrected for hemoglobin); (6) Already enrolled in the CLAP-ILD prospective cohort.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with idiopathic pulmonary fibrosis (IPF); (2) Patients with other primary lung diseases such as active pulmonary tuberculosis, bronchial asthma, chronic obstructive pulmonary disease, lung cancer, etc.; (3) Patients with a prior history of severe cardiovascular, cerebrovascular, liver, kidney, gastrointestinal, or hematological diseases, or those with malignant tumors, immunocompromised status, neurological disorders, or other serious underlying diseases; (4) Patients unable to cooperate in completing pulmonary function tests; (5) Liver function: AST or ALT >2 times the upper limit of normal, or eGFR <30 mL/min; (6) History of allergy or hypersensitivity to the components of the study drug, or any condition that, in the investigator's opinion, contraindicates the use of the study drug; (7) Pregnant women, women planning pregnancy, or lactating women; (8) Patients who have participated in another clinical trial within 3 months prior to enrollment, or who are currently participating in another clinical trial; (9) Patients for whom, based on their overall health status or compliance, the investigator believes participation in the trial may increase the risk or affect the reliability of the trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of predicted forced vital capacity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Traditional Chineses Medicine Syndrome Score;King's Brief Interstitial Lung Disease;Modified Medical Research Council;Cough And Sputum Assessment Questionnaire;Six-minute walk distance;Percentage of predicted diffusing capacity of the lungs for carbon monoxide;Incidence rate and frequency of acute exacerbations;Lung imaging;Krebs von den Lungen-6; | — |
Countries
China
Contacts
Public ContactChenYuanbin
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed