Clinical Trial of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis

Launched by WANGJING HOSPITAL, CHINA ACADEMY OF CHINESE MEDICAL SCIENCES · Aug 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether combining Huoluo Pills, a traditional Chinese medicine, with Iguratimod Tablets, a conventional medication, can better treat rheumatoid arthritis (RA) compared to using Iguratimod alone. RA is a condition that causes joint pain and swelling. This study will include 240 adults diagnosed with RA who also fit specific traditional Chinese medicine patterns called "Wind-Damp Obstruction" or "Cold-Damp Obstruction," which describe certain symptoms and signs related to their joint pain and overall health.

If you join the study, you will be randomly placed into one of two groups: one will take both Huoluo Pills and Iguratimod Tablets, and the other will take only Iguratimod Tablets. Treatment will last for 12 weeks. Doctors will check how well the treatments work by measuring improvements in joint symptoms and overall health, and they will also monitor safety through regular physical exams and lab tests. To join, you must be between 18 and 70 years old, have a confirmed RA diagnosis, and meet specific criteria related to your disease activity and current medications. People with certain other health problems or recent use of some medications will not be able to participate. This study aims to find out if adding Huoluo Pills can provide better relief for RA symptoms safely.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who meet the Western medicine classification criteria for rheumatoid arthritis (RA) launched by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2010 and have been clearly diagnosed with RA.
• • 2. 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)".
• • 3. 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.
• • 4. Male or female subjects aged ≥ 18 years old and ≤ 70 years old.
• • 5. Subjects who have not used iguratimod and Huoluo Pills within 4 weeks before the first administration of the investigational drug.
• • 6. 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/week leflunomide ≤ 20 mg/day hydroxychloroquine ≤ 400 mg/day).
• • 7. 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.
• • 8. Subjects who are receiving hormone treatment during screening should have a stable condition (limited to oral administration of ≤ 10 mg/d 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.
• • 9. 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.
• Exclusion Criteria:
• • 1. 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;
• • 2. 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;
• • 3. Patients who have received treatment with biological agents within 12 weeks before the first administration of the test drug;
• • 4. 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. ;
• • 5. Those known to have tuberculosis HIV hepatitis B hepatitis C syphilis or other active or chronic persistent infections;
• • 6. Those who are allergic to the drugs involved in the research protocol or have contraindications to their use;
• • 7. 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;
• • 8. 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/min/1.73m²; 2) Hemoglobin \< 90 g/L or white blood cell count \< 3.0×10⁹/L or neutrophil count \< 1.5×10⁹/L or lymphocyte count \< 0.5×10⁹/L or platelet count \< 90×10⁹/L;
• • 9. Pregnant or lactating women those with a fertility plan or those planning to donate sperm or eggs;
• • 10. Those who are participating in other clinical trials before screening;
• • 11. Those whom the investigator deems to have other factors that make them unsuitable to participate in this trial.