Rheumatoid Arthritis
Conditions
Interventions
Control group:Iguratimod Tablets
Trial group:Huoluo Pills + Iguratimod Tablets
Sponsors
Wangjing Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion 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
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 < 3.0×10?/L or neutrophil count < 1.5×10?/L or lymphocyte count < 0.5×10?/L or platelet count < 90×10?/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving ACR20 ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of the detected value of C-reactive protein (CRP) compared with the baseline.;The proportion of subjects with a CDAI score = 2.8;The change of HAQ-DI score compared with the baseline;The changes of the scores of each dimension of the quality of life (SF-36) compared with the baseline respectively.;The change of CDAI score compared with the baseline;The change of SDAI score compared with the baseline;The change of rheumatoid factor (RF) compared with the baseline.;The proportion of subjects achieving ACR20;The low activity rate of DAS28 (ESR);The change of TCM syndrome score compared with the baseline and the effective rate;The low activity rate of DAS28 (CRP);The proportion of subjects with an SDAI score = 3.3;The change of the detected value of erythrocyte sedimentation rate (ESR) compared with the baseline.;The change of DAS28 (ESR) score compared with the baseline;The changes of coagulation - related indexes compared with the baseline.;The change of DAS28 (CRP) score compared with the baseline ;The proportion of subjects with a CDAI score = 10;The change of the Visual Analogue Scale (VAS) score of the doctor's overall assessment of disease activity (EH) compared with the baseline.;The change of the Visual Analogue Scale (VAS) score of the subjects' assessment of articular pain (PtAAP) compared with the baseline.;The remission rate of DAS28 (CRP);The change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score in disease treatment compared with the baseline.;The change of DAS28 (CRP) score compared with the baseline;The change of the inflammatory factor interleukin - 6 (IL - 6) compared with the baseline.;The dosage of Loxoprofen Sodium Tablets;The change of the Visual Analogue Scale (VAS) score of the subjects' overall assessment of disease activity (GH) compared with the baseline.;The proportion of subjects with an SDAI score = 11;The remission rate of DAS28 (ESR);The proportion of subjects with ACR70;The proportion of | — |
Countries
China
Contacts
Public ContactCao Wei
Wangjing Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed