Rheumatoid Arthritis
Conditions
Interventions
experimental group:Danggui Niantong Decoction combined with methotrexate
control group:methotrexate alone
Sponsors
Dazu District Hospital of Traditional Chinese Medicine Chongqing
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Meet the diagnostic criteria: Rheumatoid Arthritis (RA) according to the 2010 ACR/EULAR classification criteria for rheumatoid arthritis. Dampness-Heat Obstruction Syndrome (Shi Re Bi Zu Zheng) according to the 2018 Guideline for Syndrome Differentiation and Treatment Integration of Rheumatoid Arthritis. Patients must present with either: Two main symptoms: Joint redness swelling heat and pain; OR Heat sensation on joint palpation or subjective feeling of joint heat. One main symptom AND two secondary symptoms: Joint localized skin redness; Fever; Restlessness; Thirst or thirst without desire to drink; Yellow urine. Age: Between 18 and 70 years old. Methotrexate Eligibility: No obvious contraindications to methotrexate allowing for its use in treatment. Washout Period: No use within 1 month prior to enrollment of: Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) Glucocorticoids (steroids) Biological agents (bDMARDs) Small molecule targeted drugs (e.g. tsDMARDs/JAK inhibitors) Tripterygium preparations (e.g. Tripterygium wilfordii hook F). Disease Activity: DAS28-CRP score > 3.2 indicating moderate to high disease activity based on clinical assessment. Informed Consent: All patients must provide written informed consent.
Exclusion criteria
Exclusion criteria: Lactating or pregnant women. White blood cell (WBC) count upper limit of normal (ULN). Presence of active hepatitis B infection active tuberculosis (TB) or a history of HIV infection or malignancy/cancer. Poorly controlled serious internal medical conditions (e.g. severe hypertension diabetes mellitus etc.). Patients unable to cooperate due to cognitive impairment. History of allergy to methotrexate or any component of Danggui Niantong Decoction (Chinese Angelica Decoction for Relieving Pain).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity Score in 28 joints using C-reactive protein(DAS28-CRP); | — |
Secondary
| Measure | Time frame |
|---|---|
| American College of Rheumatology 20%/50% Improvement Criteria (ACR20/ACR50);Visual Analog Scale (VAS) for Pain Assessment; | — |
Countries
china
Contacts
Public ContactChenWen
Dazu District Hospital of Traditional Chinese Medicine Chongqing
Outcome results
None listed