[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601833":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":29,"collaborators":31,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":71,"whyStopped":25,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"Wangjing Hospital, China Academy of Chinese Medical Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Trial group","EXPERIMENTAL","Huoluo Pills + Iguratimod Tablets",[13,14],"Drug: Huoluo Pills","Drug: Iguratimod Tablets",{"label":16,"type":6,"description":17,"interventionNames":18},"Control group","Iguratimod Tablets",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Huoluo Pills","Huoluo Pills: Orally take 1 pill once, twice a day (swallow with warm water)",[9],null,{"type":21,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Iguratimod Tablets: Orally take 1 tablet once, twice a day (one tablet in the morning and one in the evening, after meals)",[16,9],{"type":30,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[32,35,37,39,41,43,45,47,49],{"name":33,"class":34},"Institute of Science, Beijing Tongrentang Co., Ltd.","UNKNOWN",{"name":36,"class":34},"Beijing Leadingpharm Medicine Technology Development",{"name":38,"class":6},"Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine",{"name":40,"class":34},"The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine",{"name":42,"class":34},"The First Affiliated Hospital of Henan university of CM",{"name":44,"class":34},"Xi'an No.5 Hospital",{"name":46,"class":6},"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine",{"name":48,"class":6},"Affiliated Hospital of Shandong University of Traditional Chinese Medicine",{"name":50,"class":6},"Shaanxi Hospital of Traditional Chinese Medicine","100601833","clinical-trial-of-huoluo-pills-combined-with-iguratimod-tablets-in-the-treatment-of-rheumatoid-arthritis-100601833",false,"NCT07115641","Clinical Trial of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis","A Multicenter Clinical Randomized Controlled Trial on the Efficacy and Safety of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis","Inclusion Criteria:\n\n1. Subjects who meet the Western medicine classification criteria for rheumatoid arthritis (RA) launched by the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) in 2010 and have been clearly diagnosed with RA.\n2. Subjects who meet the diagnostic criteria for traditional Chinese medicine syndromes of \"Wind-Dampness Obstruction Syndrome (Main symptoms: ① Joint pain and swelling wandering; ② Joint pain and swelling intermittent. Secondary symptoms: ① Aversion to wind or sweating; ② Headache; ③ Heaviness of the limbs. Tongue and pulse manifestations: Pale red tongue thin white coating slippery or floating pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)\" or \"Cold-Dampness Obstruction Syndrome (Main symptoms: ① Cold joint pain the joints feel cold to the touch and the skin color is not red; ② The pain worsens when exposed to cold and alleviates when warmed. Secondary symptoms: ① Joint stiffness limited flexion and extension; ② Cold limbs or aversion to cold and preference for warmth; ③ Bland taste in the mouth without thirst. Tongue and pulse manifestations: Enlarged tongue body pale tongue white or greasy coating wiry or tight pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)\".\n3. Subjects with a Disease Activity Score in 28 joints (DAS28) (ESR) score \\> 2.6 and ≤ 5.1 or a DAS28 (CRP) score \\> 2.3 and ≤ 4.1.\n4. Male or female subjects aged ≥ 18 years old and ≤ 70 years old.\n5. Subjects who have not used iguratimod and Huoluo Pills within 4 weeks before the first administration of the investigational drug.\n6. If the subject is receiving treatment with traditional disease-modifying antirheumatic drugs (DMARDs) during screening monotherapy with one of methotrexate (MTX) leflunomide or hydroxychloroquine is allowed and the dosage should be stable for at least 12 weeks before the first administration of the investigational drug (MTX dosage ≤ 15 mg\u002Fweek leflunomide ≤ 20 mg\u002Fday hydroxychloroquine ≤ 400 mg\u002Fday).\n7. Subjects who are receiving treatment with non-steroidal anti-inflammatory drugs (NSAIDs) during screening should have a stable dosage for at least 2 weeks before the first administration of the investigational drug and maintain the same dosage during the trial.\n8. Subjects who are receiving hormone treatment during screening should have a stable condition (limited to oral administration of ≤ 10 mg\u002Fd prednisone acetate or equivalent dose) for at least 4 weeks before the first administration of the investigational drug and maintain stable treatment during the trial.\n9. Subjects who voluntarily agree to participate in this trial sign a written informed consent form are able to follow the visit and related procedures specified in the protocol and have good compliance.\n\nExclusion Criteria:\n\n1. Those who have used plant medicine preparations such as Tripterygium glycosides total glucosides of paeony sinomenine or other traditional Chinese medicine preparations that affect the evaluation of the therapeutic effect within 4 weeks before the first administration of the test drug;\n2. Those who have received intramuscular injection intravenous injection or intra-articular injection of glucocorticoid treatment within 4 weeks before the first administration of the test drug;\n3. Patients who have received treatment with biological agents within 12 weeks before the first administration of the test drug;\n4. Those who suffer from active gastrointestinal diseases (such as peptic ulcers) severe interstitial lung diseases low bone marrow function severe cardiovascular and cerebrovascular diseases (such as acute myocardial infarction unstable angina pectoris intracerebral hemorrhage transient ischemic attack) severe organic lesions such as poorly controlled diabetes mellitus or those who have a history of malignant tumors in the past 5 years or those with mental illnesses. ;\n5. Those known to have tuberculosis HIV hepatitis B hepatitis C syphilis or other active or chronic persistent infections;\n6. Those who are allergic to the drugs involved in the research protocol or have contraindications to their use;\n7. Those who have received live vaccines within 4 weeks before screening or inactivated vaccines within 2 weeks before screening or those who have a vaccination plan during the trial;\n8. Those with any of the following conditions in the auxiliary examination during screening: 1) AST or ALT \\> 1.5 times the upper limit of the normal reference value or the estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73m²; 2) Hemoglobin \\\u003C 90 g\u002FL or white blood cell count \\\u003C 3.0×10⁹\u002FL or neutrophil count \\\u003C 1.5×10⁹\u002FL or lymphocyte count \\\u003C 0.5×10⁹\u002FL or platelet count \\\u003C 90×10⁹\u002FL;\n9. Pregnant or lactating women those with a fertility plan or those planning to donate sperm or eggs;\n10. Those who are participating in other clinical trials before screening;\n11. Those whom the investigator deems to have other factors that make them unsuitable to participate in this trial.","ALL","18 Years","70 Years",{"count":62,"type":63},240,"ESTIMATED","INTERVENTIONAL",[66],"NA","This study aims to systematically evaluate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of rheumatoid arthritis (RA). A total of 240 patients with RA belonging to the syndromes of Wind - Damp Obstruction or Cold - Damp Obstruction will be enrolled in 8 centers (randomly assigned to groups). The experimental group will receive oral Huoluo Pills combined with Iguratimod Tablets, while the control group will receive oral Iguratimod Tablets alone. Both groups will be administered continuously for 12 weeks.\n\nPrimary Efficacy Index: The proportion of ACR20 responders in each group at the end of treatment.\n\nKey Secondary Efficacy Index: The change in DAS28 (CRP) score from baseline in each group at the end of treatment.\n\nOther Secondary Efficacy Indexes: RF, CRP, ESR, IL - 6, ACR50, ACR70, CDAI, SDAI, HAQ - DI, SF - 36, FACIT - Fatigue, and Traditional Chinese Medicine (TCM) syndrome scores.\n\nSafety Indexes: Physical examination, blood routine, urine routine, blood biochemistry, coagulation function, etc.\n\nThis study will investigate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of RA with Wind - Damp Obstruction or Cold - Damp Obstruction syndromes.",[69],"Rheumatoid Arthritis",[22,17],"NOT_YET_RECRUITING","2025-08-06",{"date":74,"type":75},"2025-08-11","ACTUAL",{"date":74,"type":63},{"date":78,"type":63},"2026-08-31",{"name":5,"class":6}]