[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657351":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":41,"studyPopulation":29,"armGroups":42,"interventions":55,"overallOfficials":29,"centralContacts":65,"locations":75,"responsibleParty":92,"collaborators":29,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":29,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":29,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":119,"whyStopped":29,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"First People's Hospital of Hangzhou","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants Achieving Glucocorticoid Tapering to ≤7.5 mg\u002Fday at Week 24","Percentage of participants who successfully reduce their prednisone (or equivalent) maintenance dose to ≤7.5 mg\u002Fday at Week 24, without disease flare (as defined by objective pulmonary or imaging progression) and without initiating protocol-defined escalated salvage therapy.","Week 24",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Cumulative Glucocorticoid Exposure Over 24 Weeks","Area under the curve (AUC) of total glucocorticoid dose accumulated over the 24-week follow-up period.","Baseline up to Week 24",{"measure":19,"description":20,"timeFrame":21},"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.","Baseline and Week 24",{"measure":23,"description":24,"timeFrame":21},"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.",{"measure":26,"description":27,"timeFrame":28},"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.","Up to Week 24",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Background Anti-synthetase syndrome (ASS) is an autoimmune disease characterized by anti-aminoacyl-tRNA synthetase (ARS) antibodies and represents a major subtype of idiopathic inflammatory myopathy (IIM). Its clinical manifestations are heterogeneous, frequently involving the lungs, muscles, joints, and skin. Interstitial lung disease (ILD) is the most common and characteristic organ involvement, occurring in over 80% of patients and often presenting as the initial manifestation. In some patients, ASS-ILD follows a rapidly progressive course (RP-ILD), leading to acute respiratory failure within weeks or even days, with a 1-year survival rate of approximately 75%, making it a leading cause of critical illness and early death in rheumatology.\n\nCurrent Western medical treatment for ASS-ILD relies on potent immunosuppression, primarily high-dose glucocorticoids combined with conventional immunosuppressants (e.g., cyclosporine, tacrolimus, cyclophosphamide). Biologics targeting B cells (rituximab) and JAK inhibitors have also been recommended for severe or refractory cases. However, long-term high-dose glucocorticoid and immunosuppressant use presents two major challenges: difficulty in tapering without disease relapse-rapid reduction often triggers pulmonary flares, while slow tapering increases cumulative toxicity, resulting in low successful tapering rates to safe doses within 24-40 weeks in real-world practice-and significant treatment-related toxicity, with exponentially increased risk of opportunistic infections (e.g., Pneumocystis jirovecii pneumonia, invasive fungal infections, cytomegalovirus infection).\n\nIn traditional Chinese medicine (TCM), ASS-ILD is classified as \"lung impediment\"or \"lung atrophy\". Based on long-term clinical experience, our group proposes that the core pathogenesis is \"deficiency of lung collaterals as the root, with damp-heat, phlegm, and blood stasis as the manifestations.\" In the early stage, pathogenic heat and dampness obstruct the lung collaterals; as the disease progresses, chronic involvement leads to phlegm-stasis obstruction and eventually \"collateral stasis with accumulation,\" which corresponds to reticular opacities, fibrotic nodules, and linear shadows on imaging. Guided by the principle of \"unblocking collaterals to restore function,\" we developed the original Chinese herbal formula FuFei HuaZhuo TongLuo Granule (composed of Danggui, Qianghuo, Yinchen, Fangfeng, Cangzhu, Baizhu, Zhimu, Shengma, Gegen, Huangqin, Yiyiren, Ezhu, Dilong, Jiangcan, Gancao, etc.). Preliminary pilot and retrospective studies suggest that this formula may improve dyspnea, control TCM syndrome scores, facilitate glucocorticoid tapering, and reduce opportunistic infections.\n\nObjectives The primary objective is to evaluate the rate of successful safe glucocorticoid (prednisolone or equivalent) tapering to a low maintenance dose (≤7.5 mg\u002Fday) at 24 weeks with the herbal formula plus standardized Western medicine, compared with placebo plus standardized Western medicine. Secondary objectives include exploring the clinical benefits on TCM syndrome scores, disease activity, reduction of Western drug side effects, and preservation of lung function; and investigating potential molecular targets and mechanisms through immunomics and multi-omics analyses of peripheral blood and other biospecimens.\n\nStudy Design Overview This is a single-center, randomized, double-blind, placebo-controlled pragmatic clinical trial (PCT). A total of 54 eligible patients will be enrolled and randomized in a 2:1 ratio using block randomization (stratified by baseline disease severity) to either the integrative medicine group (herbal plus standardized Western medicine) or the Western medicine alone group (placebo plus standardized Western medicine). The intervention consists of daily granule administration for 12 weeks, with a total follow-up of 24 weeks. There are 8 clinical visits: baseline (week 0) and weeks 2, 4, 8, 12, 16, 20, and 24. At each follow-up visit, all patients undergo disease activity assessment (MITAX score), traditional Chinese medicine (TCM) syndrome differentiation analysis, and safety monitoring, including complete blood count, liver and renal function tests, and adverse event recording. Peripheral blood samples are collected at weeks 0, 4, 12, and 24 for immunology and metabolomics research. Pulmonary function tests and high-resolution computed tomography (HRCT) scans are performed at baseline, week 12, and week 24. Throughout the study, daily glucocorticoid dosage and concomitant medications are recorded.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Experimental: Chinese Herbal Formula plus Standardized Western Medicine","EXPERIMENTAL","Participants receive FuFei HuaZhuo TongLuo Granule (one dose daily, orally, for 12 weeks) along with standardized Western medicine (glucocorticoids plus conventional immunosuppressants) adjusted according to a disease severity-based protocol.",[48],"Drug: FuFei HuaZhuo TongLuo Granule",{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo Comparator: Placebo plus Standardized Western Medicine","PLACEBO_COMPARATOR","Participants receive matching Placebo Granule (one dose daily, orally, for 12 weeks) along with the same standardized Western medicine protocol as the experimental arm.",[54],"Drug: Placebo granule",[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":29},"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.",[44],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":29},"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.",[50],[66,71],{"name":67,"role":68,"phone":69,"phoneExt":29,"email":70},"Jiangping He","CONTACT","+86 15867170158","hejiangping@hospital.westlake.edu.cn",{"name":72,"role":68,"phone":73,"phoneExt":29,"email":74},"Jiao Huang","+86 13429110658","huangjiao@hospital.westlake.edu.cn",[76],{"facility":77,"status":29,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Hangzhou First People's Hospital","Hangzhou","Zhejiang","310006","China","CN",{"type":84,"coordinates":85},"Point",[86,87],120.16142,30.29365,{"lat":87,"lon":86},[90,91],{"name":67,"role":68,"phone":69,"phoneExt":29,"email":70},{"name":72,"role":68,"phone":73,"phoneExt":29,"email":74},{"type":93,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100657351","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-100657351",false,"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","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","Inclusion Criteria: (1) Western medicine diagnostic criteria: meeting the 2017 EULAR\u002FACR 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\u002Fday prednisone (or equivalent). (5) Informed consent: the patient or his\u002Fher legal representative voluntarily signs the written informed consent form.\n\nExclusion 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\u002Frenal dysfunction (ALT\u002FAST \\> 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 \\\u003C 60 mmHg with PaCO₂ ≤ 50 mmHg; Type II respiratory failure: at sea level and at rest, arterial blood gas showing PaO₂ \\\u003C 60 mmHg with PaCO₂ \\> 50 mmHg. If the patient is already receiving high-flow oxygen therapy or non-invasive\u002Finvasive 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.","ALL","18 Years","70 Years",{"count":105,"type":106},54,"ESTIMATED","INTERVENTIONAL",[109],"NA","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:\n\nDoes 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\u002Fday) at 24 weeks, compared with placebo plus standardized western medicine?\n\nDoes 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?\n\nWhat medical problems do participants have when taking this herbal formula?\n\nResearchers 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.\n\nParticipants will:\n\nTake the Chinese herbal granule or a placebo every day for 12 weeks\n\nVisit the clinic at 8 time points: baseline, weeks 2, 4, 8, 12, 16, 20, and 24 for checkups and tests\n\nUndergo pulmonary function tests (at baseline, week 12, and week 24) and high-resolution CT scans (at baseline, week 12, and week 24)\n\nReceive 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\n\nProvide peripheral blood samples at weeks 0, 4, 12, and 24 for exploratory immunology and metabolomics research\n\nRecord their daily glucocorticoid dosage and concomitant medications throughout the study",[112,113],"Anti-Synthetase Syndrome","Interstitial Lung Disease (ILD)",[115,116,117,118],"Anti-synthetase syndrome associated Interstitial Lung Disease","Traditional Chinese Medicine","Glucocorticoid Taper","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-09-17",{"date":122,"type":123},"2026-09-23","ACTUAL",{"date":125,"type":106},"2026-10-10",{"date":127,"type":106},"2028-12-31",{"name":5,"class":6},1]