Rheumatoid arthritis with cold dampness obstruction and depression Musculoskeletal Diseases
Conditions
Interventions
Intervention group: Participants will receive Wenyang Jieyu granules (1 dose daily, dissolved in water and taken in two divided doses) in combination with methotrexate tablets (10 mg, taken orally onc
Sponsors
Beijing Municipal Health Commission
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent form after understanding the full trial process. 2. Meet the 2010 ACR/EULAR diagnostic criteria for Rheumatoid Arthritis (RA). 3. Meet the Traditional Chinese Medicine (TCM) pattern differentiation of cold-dampness obstruction with depression. 4. Meet the diagnostic criteria for an anxiety and/or depressive state. 5. Aged between 18 and 70 years, inclusive, any gender. 6. Males or females with no plans for childbirth; or are peri- or post-menopausal women. 7. Patients with mild to moderate disease activity, defined as a DAS28-ESR score > 2.6 and = 5.1. 8. No severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, or autoimmune liver disease. 9. Have not participated in any other drug trials within 1 month prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Pregnant, planning to become pregnant, or breastfeeding women. 2. Patients with active liver disease or abnormal liver function, defined as Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) levels > 1.5 times the upper limit of normal (ULN). 3. Impaired renal function, defined as serum creatinine above the upper limit of normal. 4. Peripheral white blood cell count < 3.0×10?/L, confirmed anemia (hemoglobin < 80g/L), platelet count < 80×10?/L, or have other hematological disorders. 5. History of intolerance or significant adverse reaction to methotrexate, OR an inadequate response to a prior course of treatment with methotrexate at a dose of =10 mg/week for at least 12 weeks. 6. Patients with acute or chronic infectious diseases. 7. Patients with severe arrhythmia found on electrocardiogram (ECG). 8. Patients with a current or a history of malignancy. 9. Patients with a psychiatric disorder, a history of alcohol abuse, OR a history of drug abuse. 10. A confirmed diagnosis of another connective tissue disease, OR failure to achieve disease control within the 3 months prior to enrollment despite receiving guideline-recommended standard therapy with immunosuppressants or biologic agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response measured using the American College of Rheumatology (ACR) 20 criteria at 12 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease Activity Score (DAS28) measured using the DAS28 assessment at weeks 0, 4, 8, and 12. 2. Proportion of participants achieving ACR50 response measured using the American College of Rheumatology (ACR) 50 criteria at weeks 0, 4, 8, and 12. 3. Proportion of participants achieving ACR70 response measured using the American College of Rheumatology (ACR) 70 criteria at weeks 0, 4, 8, and 12. 4. Overall response rate of Traditional Chinese Medicine (TCM) syndromes measured using TCM syndrome scoring criteria at weeks 0, 4, 8, and 12. 5. Patient-reported outcomes measured using the Patient-Reported Outcome (PRO) scale for RA at weeks 0, 4, 8, and 12. 6. Disability index measured using the Health Assessment Questionnaire (HAQ) at weeks 0, 4, 8, and 12. 7. Anxiety symptoms measured using the 14-item Hamilton Anxiety Scale (HAMA-14) at weeks 0, 4, 8, and 12. 8. Depression symptoms measured using the 24-item Hamilton Depression Scale (HAMD-24) at weeks 0, 4, 8, and 12. 9. Joint inflammation and damage measured using the 7-joint ultrasound score (US7) at weeks 0, 4, 8, and 12. | — |
Countries
China
Contacts
Public ContactWeizhong Li
Outcome results
None listed