Pulmonary fibrosis
Conditions
Interventions
Control Group:Placebo + CTD-based treatment + routine comprehensive therapy
Treatment group:Xingqi Huoxue Granules + CTD Basic Therapy + Conventional Comprehensive Therapy
Sponsors
Hospital of Chengdu University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 to 80 years, male or female; 2) Meet the diagnostic criteria for CTD-ILD in Western medicine, including systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, or Sjögren's syndrome, as well as the Chinese medicine syndrome criteria (qi deficiency and blood stasis); 3) Baseline FVC = 50% of the predicted normal value, DLCO = 30% of the predicted normal value. Pulmonary function tests must be obtained under conditions without pulmonary infection, colds, or other known events that could affect the test results (e.g., rib fractures, chest pain, etc.); 4) Expected survival of more than 1 year. Survival rate is predicted through comprehensive GAP functional staging (participant's gender, age, FVC, and DLCO scores); 5) If previously treated with nintedanib and/or pirfenidone and/or acetylcysteine, such treatments must have been discontinued for =12 weeks prior to baseline; 6) Patients are able to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Evidence of any of the following significant obstructive pulmonary diseases: a. The ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) 10 mmol/L; 5) AST or ALT > 1.5 × ULN or bilirubin > 1.5 × ULN; 6) Serum creatinine > 1.0 × ULN at the first visit; 7) New York Heart Association (NYHA) functional class = III; 8) Thrombotic risk, including a genetic predisposition to thrombotic events (e.g., stroke or transient ischemic attack) within the past year; 9) Coagulation studies showing PT > 14 seconds, or APTT > 43 seconds, or TT > 21 seconds; 10) Interstitial lung disease (ILD) other than CTD-ILD, including but not limited to: idiopathic interstitial pneumonia; pulmonary diseases related to exposure to fibrotic agents, environmental toxins, or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis or infectious diseases (e.g., tuberculosis). If the diagnosis is unclear, serological testing and/or review by an expert in the relevant field should be conducted to confirm the diagnosis of other types of ILD; 11) History of other types of respiratory diseases, including diseases or disorders of the airways, lung parenchyma, pleural cavity, mediastinum, diaphragm, or chest wall, which the investigator believes may affect the primary endpoint of the study or otherwise impact the participant's involvement in the study; 12) Current or past history of any malignancy, including any that may lead to death or require major medical or surgical intervention within the next year; 13) History of hypersensitivity or allergy to any prescribed medications; 14) Pregnant or breastfeeding women; 15) Any suicidal behavior in the past 2 years (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory action or attitude); 16) The investigator determines that the participant is unable to fully participate and complete the study, for reasons including inability to comply with study procedures and treatment, addiction, or any other related medical or psychiatric conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Vital Capacity; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-minute walking distance;DLCO;SGRQ;KBILD-B;mMRC;Blood Oxygen Saturation;TCM Syndrome Score;Serum triglycerides;Serum total cholesterol;Serum low-density lipoprotein;Serum high-density lipoprotein;TGF-ß1;HYP; | — |
Countries
China
Contacts
Public ContactWangFei
Hospital of Chengdu University of TCM
Outcome results
None listed