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NCT07836790

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

Sponsor: First People's Hospital of Hangzhou

View on ClinicalTrials.gov

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

Official title: A Prospective, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pragmatic Clinical Trial of Fufei Huazhuo Tongluo Formula Combined With Standardized Western Medicine for Glucocorticoid-Sparing Efficacy in Patients With Anti-Synthetase Syndrome-Associated Interstitial Lung Disease

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-10

Completion Date

2028-12-31

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Anti-Synthetase Syndrome Interstitial Lung Disease (ILD)

Interventions

DRUG

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.

DRUG

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.

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.

Locations (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China