The goal of this clinical trial is to learn if the traditional Chinese medicine formula "FuFei HuaZhuo TongLuo Granule" combined with standardized western medicine works to treat anti-synthetase syndrome-associated interstitial lung disease (ASS-ILD). It will also learn about the safety of this combined therapy. The main questions it aims to answer are:
Does the Chinese herbal formula plus standardized western medicine increase the proportion of patients who successfully reduce their glucocorticoid dose to a low maintenance level (prednisone ≤ 7.5 mg/day) at 24 weeks, compared with placebo plus standardized western medicine?
Does this herbal formula provide additional clinical benefits in terms of glucocorticoid sparing, delaying lung function decline, reducing infection risk, and improving traditional Chinese medicine syndrome scores?
What medical problems do participants have when taking this herbal formula?
Researchers will compare the Chinese herbal granule to a placebo granule (a look-alike substance that contains no active ingredients) to see if the herbal formula works to treat ASS-ILD. Both groups will receive standardized western medicine treatment based on disease severity.
Participants will:
Take the Chinese herbal granule or a placebo every day for 12 weeks
Visit the clinic at 8 time points: baseline, weeks 2, 4, 8, 12, 16, 20, and 24 for checkups and tests
Undergo pulmonary function tests (at baseline, week 12, and week 24) and high-resolution CT scans (at baseline, week 12, and week 24)
Receive disease activity assessments (MITAX score), traditional Chinese medicine syndrome evaluations, and safety monitoring (blood routine, liver and kidney function, adverse event recording) at each follow-up visit
Provide peripheral blood samples at weeks 0, 4, 12, and 24 for exploratory immunology and metabolomics research
Record their daily glucocorticoid dosage and concomitant medications throughout the study