Progressive pulmonary interstitial fibrosis
Conditions
Interventions
Experimental group:Chunhua Yifu Granules (oral) + standard Western medical treatment
Control group:Standard treatment with Western medicine
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18-75 years, gender. (2) Diagnosed with progressive pulmonary fibrosis according to the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelines for Adult Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, with unexplained ILD in the past year that cannot be explained by IPF, and must meet at least 2 of the following 3 criteria: 1) worsening respiratory symptoms; 2) physiological progression (mainly referring to pulmonary function, a. absolute FVC decline =5% over 1 year of follow-up, b. absolute DLCO decline =10% over 1 year of follow-up); 3) imaging progression; (3) If currently using pirfenidone or nintedanib, must have received a stable dose at least 3 months prior to screening and during the trial period; immunosuppressants such as mycophenolate mofetil, mycophenolic acid, azathioprine, and/or tacrolimus are only allowed if the subject has been on a stable dose for at least 6 months prior to screening. (4) Meets TCM differentiation of lung qi deficiency with phlegm-dampness and blood stasis, with main clinical symptoms: chest oppression, shortness of breath exacerbated by activity, cough, fatigue, spontaneous sweating, susceptibility to colds, pale white tongue, and thin pulse. Secondary symptoms: white sputum, small amount of sputum, bodily fatigue, lack of breath, aversion to wind, thin coating, white coating, deep pulse, weak pulse. (5) Possesses good ability to read, understand, and write research-related materials, and voluntarily adheres to all trial requirements. (6) Voluntarily participates in the study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with confirmed pulmonary infections, or those with concurrent lung cancer, tuberculosis, or other malignant tumors. Patients who have undergone surgeries such as pulmonary resection or lung transplantation that may affect pulmonary function. Patients dependent on mechanical ventilation, such as ventilators, to maintain pulmonary function. (2) Patients with acute exacerbation of pulmonary fibrosis within the past 4 weeks or during the screening period. (3) Patients who have undergone major or intermediate-sized surgery within the past 3 months. (4) Patients with abnormal liver or kidney function (laboratory results showing serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = twice the upper limit of normal as defined by the center, or serum creatinine (Scr) = twice the upper limit of normal as defined by the center). (5) Patients with a history or current severe cardiovascular, cerebrovascular, or hematological diseases, or those who have undergone bone marrow transplantation, Alzheimer's disease, mental disorders, myocardial infarction within the past 6 months, or other severe organic diseases that are either uncontrolled or under active treatment. (6) Patients with known allergies to any components of the investigational drugs. (7) Patients who have used systemic corticosteroids equivalent to >15 mg/day of prednisone within the past 4 weeks or during the study period; or patients who are concomitantly taking other traditional Chinese medicine formulations for anti-pulmonary fibrosis during the study period. (8) Patients with a history of long-term alcohol abuse or substance abuse. (9) Pregnant or breastfeeding women; or patients with plans for pregnancy during the study period. (10) Patients with mental disorders or inability to adhere to the prescribed medication regimen. (11) Patients who have participated in other clinical trials within the past 3 months (excluding patients who did not receive investigational drugs/devices). (12) Patients whom the investigator considers unsuitable for participation in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Capacity (FVC) (ml); | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital Capacity (FVC) (ml);Pulmonary function-related indicators;Traditional Chinese Medicine Symptom Quantification Scoring System;Quality of Life Rating;Lung HRCT; | — |
Countries
China
Contacts
Public ContactZhang Yiwén
Zhejiang Provincial People's Hospital
Outcome results
None listed