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
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Parallel
FuFei HuaZhuo TongLuo Granule
DrugFuFei HuaZhuo TongLuo Granule is a traditional Chinese medicine formulation provided as oral granules. One dose (divided into two equal portions) is taken orally in the morning and evening daily for 12 consecutive weeks. The granule contains the following herbal ingredients: Danggui, Qianghuo, Yinchen, Fangfeng, Cangzhu, Baizhu, Zhimu, Shengma, Gegen, Huangqin, Yiyiren, Ezhu, Dilong, Jiangcan, Gancao.
Placebo granule
DrugMatching Placebo Granule is provided as oral granules with identical appearance, taste, odor, packaging, and labeling to the FuFei HuaZhuo TongLuo Granule. It contains inactive ingredients and is taken orally, one dose (divided into two equal portions) in the morning and evening daily for 12 consecutive weeks.
Proportion of Participants Achieving Glucocorticoid Tapering to ≤7.5 mg/day at Week 24
Percentage of participants who successfully reduce their prednisone (or equivalent) maintenance dose to ≤7.5 mg/day at Week 24, without disease flare (as defined by objective pulmonary or imaging progression) and without initiating protocol-defined escalated salvage therapy.
Cumulative Glucocorticoid Exposure Over 24 Weeks
Area under the curve (AUC) of total glucocorticoid dose accumulated over the 24-week follow-up period.
Proportion of Participants with ≥50% Reduction in Traditional Chinese Medicine Syndrome Score
Proportion of participants achieving at least a 50% reduction from baseline in the total Traditional Chinese Medicine (TCM) syndrome score at Week 24.
Proportion of Participants with Stable or Improved Forced Vital Capacity (FVC)
Proportion of participants with FVC% predicted value showing a decline of less than 5% from baseline (i.e., stable or improved) at Week 24.
Incidence of Severe Opportunistic Infections Requiring Hospitalization
Cumulative incidence of severe opportunistic infections (e.g., Pneumocystis jirovecii pneumonia, invasive fungal infections, cytomegalovirus infection) requiring hospitalization over the 24-week follow-up period.
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