Rheumatoid Arthritis–Associated Interstitial Lung Disease
Conditions
Interventions
Treatment group:Fengshi Feibi Granules, Leflunomide, Prednisone, Cyclophosphamide
Control group:Fengshi Feibi Granules Placebo, Leflunomide, Prednisone, Cyclophosphamide
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Age between 18 and 75 years old; (2)Diagnosed with rheumatoid arthritis according to established criteria and confirmed diagnosis of interstitial lung disease; (3)DAS28 score less than 5.1; (4)Traditional Chinese medicine syndrome type corresponds to Qi deficiency and blood stasis; (5)Signed informed consent and able to comply with the trial procedures.
Exclusion criteria
Exclusion criteria: (1)Presence of other types of autoimmune diseases (e.g. ankylosing spondylitis systemic lupus erythematosus dermatomyositis Sjögrens syndrome systemic sclerosis etc.); (2)Acute exacerbation of RA-ILD significant worsening of dyspnea within the past 30 days or lung function showing forced vital capacity (FVC) < 45% of predicted value or diffusing capacity for carbon monoxide (DLCO) < 40% of predicted value within the past 30 days; (3)Women who are pregnant breastfeeding or planning to conceive; (4)Presence of other pulmonary diseases such as pulmonary tuberculosis or lung abscess; (5)History of malignant tumors or tuberculosis; (6)Severe hypertension diabetes or severe cardiac hepatic or renal failure; (7)Patients currently receiving treatment with other medications that may cause interstitial lung disease or those who have changed their treatment regimen within the past month; (8)Use of other traditional Chinese medicine formulations biologics or antifibrotic agents such as pirfenidone or nintedanib within the past month; (9)Poor compliance or inability to meet the trial requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28 score;Vital Capacity (VC); | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score;Joint ultrasound;TCM Syndrome Scoring;Kings Brief Interstitial Lung Disease Questionnaire (KBILD);Krebs von den Lungen-6 (KL-6);Lung Function;High-resolution computed tomography of the lung; | — |
Countries
China
Contacts
Public ContactYongjun Wang
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed