A Randomized, Double-Blind, Placebo-Controlled Trial of Fufei Huazhuo Tongluo Formula Combined With Standardized Medicine in Patients With Anti-Synthetase Syndrome-Associated Interstitial Lung Disease

NCT07836790 · tracked via the Priya Life Science China tracker

Sponsor

First People's Hospital of Hangzhou

Phase

Not applicable

Started

2026-10-10

Last updated

2026-09-23

Condition(s) studied

Anti-Synthetase SyndromeInterstitial Lung Disease (ILD)

Investigational drug(s) / intervention(s)

FuFei HuaZhuo TongLuo GranulePlacebo granule

FuFei HuaZhuo TongLuo Granule: FuFei 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: Matching 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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: (1) Western medicine diagnostic criteria: meeting the 2017 EULAR/ACR classification criteria for idiopathic inflammatory myopathy, with positive anti-synthetase antibodies (e.g., anti-Jo-1, PL-7, PL-12, etc.), and confirmed interstitial lung disease (ILD) by high-resolution computed tomography (HRCT). (2) Traditional Chinese Medicine (TCM) syndrome differentiation criteria: meeting the criteria for either "damp-heat obstructing collaterals syndrome" or "collateral stasis with accumulation syndrome." Damp-heat obstructing collaterals syndrome: satisfying 2 major symptoms + 1 minor symptom + tongue and pulse manifestations, or 1 major symptom + 2 minor symptoms + tongue and pulse manifestations (major symptoms include heavy and aching muscles, joint aching, cough and wheezing with profuse phlegm, etc.; red tongue with yellow, greasy coating, and slippery, rapid pulse). Collateral stasis with accumulation syndrome: satisfying 2 major symptoms + 1 minor symptom + tongue and pulse manifestations, or 1 major symptom + 2 minor symptoms + tongue and pulse manifestations (major symptoms include stabbing muscle pain and weakness, fixed joint pain, shortness of breath and panting, etc.; dark tongue with ecchymotic spots, greasy coating, and deep, wiry or slippery pulse). (3) Age and sex: 18-70 years of age, both sexes eligible. (4) At screening, in a state of newly diagnosed or relapsed ASS-ILD, and receiving a glucocorticoid dose of ≥30 mg/day prednisone (or equivalent). (5) Informed consent: the patient or his/her legal representative voluntarily signs the written informed consent form. Exclusion Criteria: (1) Concomitant other severe diseases: other active connective tissue diseases (e.g., SLE, RA, pSS, etc.); severe non-rheumatic cardiovascular diseases (e.g., uncontrolled heart failure, recent myocardial infarction), malignancy, or severe hepatic/renal dysfunction (ALT/AST \> 3× ULN, Cr \> 1.5× ULN). (2) Respiratory failure: At baseline, the presence of any one of the following criteria is defined as respiratory failure, and the patient should be excluded: Type I respiratory failure: at sea level and at rest, arterial blood gas showing PaO₂ \< 60 mmHg with PaCO₂ ≤ 50 mmHg; Type II respiratory failure: at sea level and at rest, arterial blood gas showing PaO₂ \< 60 mmHg with PaCO₂ \> 50 mmHg. If the patient is already receiving high-flow oxygen therapy or non-invasive/invasive mechanical ventilation, respiratory failure is considered present regardless of blood gas values, and the patient should be excluded. (3) Interference from recent treatment history: receipt of hematopoietic stem cell transplantation within the past 3 months; continuous use of other systemic Chinese herbal decoctions or granules within 2 weeks before enrollment. (4) Special populations: pregnant or breastfeeding women. (5) Psychiatric or cognitive impairment: presence of severe psychiatric illness or cognitive impairment that prevents cooperation with clinical follow-up and assessments.

Primary outcome measure(s)

Proportion of Participants Achieving Glucocorticoid Tapering to ≤7.5 mg/day at Week 24 — 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.

Trial sites (1)

Facility	City	Region	Status
Hangzhou First People's Hospital	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07836790 on ClinicalTrials.gov ↗ ← All trials in China