Rheumatoid Arthritis
Conditions
Interventions
Healthy Control Group:No intervention
Wind-Cold-Dampness Obstruction TCM Treatment Group:Methotrexate + Zhengqing Fengtongning Sustained-Release Tablets
Wind-Cold-Dampness Obstruction Control Group:Methotrexate Monotherapy
RA without Abnormal Lipid Metabolism Group:Conventional Therapy
Liver-Kidney Deficiency Control Group:Methotrexate Monotherapy
Liver-Kidney Deficiency TCM Treatment Group:Methotrexate + Wangbi Capsules
RA with Abnormal Lipid Metabolism Group:Conventional Therapy
Sponsors
Dongguan Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Meeting 2010 ACR/EULAR classification criteria for rheumatoid arthritis; 2: Asian ethnicity, aged 18-70 years; 3: Voluntary participation with signed informed consent; 4: Stable oral methotrexate =4 weeks; 5: Diagnosed as Wind-Cold-Dampness Obstruction or Liver-Kidney Deficiency Syndrome per Chinese Diagnostic Standards; 6: Stable medication dosage =1 month prior to enrollment; 7: Presence of joint swelling/pain/morning stiffness (=1 hour); 8: Normal liver and kidney function.
Exclusion criteria
Exclusion criteria: 1: DAS28 score over 5.1 or high disease activity 2: Comorbid immune diseases (e.g., SLE/Sjögren's syndrome); 3: Chronic liver/kidney/GI diseases or hematologic malignancies; 4: Biologic/glucocorticoid/non-MTX immunosuppressant use within 2 months; 5: Methotrexate allergy; 6: Zhengqing Fengtongning/Wangbi Capsule treatment within 2 months; 7: JAK inhibitor/glucocorticoid therapy; 8: Comorbid tuberculosis/malignancies/active infections; 9: Severe cardiocerebral/hepatic/renal diseases (stroke/CHD/liver failure); 10: Pregnancy or lactation; 11: Psychiatric disorders or contraindications per investigator; 12: Participation in other clinical trials within 2 months.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Alanine Aminotransferase (ALT);Serum Creatinine (Scr);Serum TNF-a Levels;Serum IL-6 Levels;Serum IL-10 Levels;TCM Syndrome Score (Wind-Cold-Dampness/Liver-Kidney Deficiency);Disease Activity Score 28;C-reactive protein;erythrocyte sedimentation Rate,ESR;anti-cyclic peptide containing citrulline,anti-CCP; | — |
Primary
| Measure | Time frame |
|---|---|
| Differentially Methylated Regions;Dampness Syndrome Score;HLA genotyping; | — |
Countries
Conventional Therapy
Contacts
Public ContactYaoYunda
Dongguan Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed