Rheumatoid Arthritis
Conditions
Interventions
Treatment group:In addition to the control group's treatment, the herbal decoction "He Bi Fang" (comprising: Angelica sinensis, Paeonia lactiflora, Atractylodes macrocephala, Atractylodes lancea, Sino
Control Group:Oral methotrexate tablets (MTX) (2.5 mg/tablet), gradually increase from 7.5 mg weekly to 12.5 mg weekly over 4 weeks, once weekly. Folic acid tablets, take 10 mg of folic acid tablets (
Sponsors
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for RA in both traditional Chinese and Western medicine, and has the TCM syndrome of liver-spleen dysfunction; (2) RA disease duration <1 year (early RA); (3) Age between 18 and 65 years; (4) No use of steroids or other disease-modifying anti-rheumatic drugs (DMARDs) in the past 4 weeks; if such treatment has been received, it must be limited to one type, and the dosage must have been stable for at least 30 days; (5) All patients voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Age over 65 years or under 18 years; (2) Pregnant or breastfeeding women, etc.; (3) Patients with severe diseases of important organs such as heart, brain, lungs, kidneys, or hematopoietic system; (4) Confirmed cases of RA but with severe extrarticular manifestations such as vasculitis, interstitial pneumonia, etc., requiring glucocorticoids; patients with acute or chronic infectious diseases, malignant tumors, or mental disorders; (5) Patients with allergic constitutions or intolerance to traditional Chinese medicine; (6) Patients with active digestive tract diseases, including celiac disease, inflammatory bowel disease, gastrointestinal bleeding, or digestive tract malformations; (7) Patients who underwent barium meal, colonoscopy, enema, or have a history of acute gastroenteritis within 2 weeks prior to enrollment; (8) Patients currently using or who have used antibiotics, laxatives, probiotics, or prebiotics within 1 month prior to enrollment; (9) Patients who have undergone cholecystectomy or digestive tract surgery, or endoscopic digestive tract surgery within 6 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythrocyte Sedimentation Rate (ESR);C-reactive protein (CRP);Tumor Necrosis Factor Alpha (TNF-a);Interleukin-1ß (IL-1ß);Interleukin 6 (IL-6);Brain-Derived Neurotrophic Factor (BDNF);TrkB receptor tyrosine kinase; | — |
Secondary
| Measure | Time frame |
|---|---|
| Basic Vital Signs: Body Temperature, Heart Rate, Respiration, Blood Pressure.;Laboratory tests: Complete blood count (CBC), Urinalysis, Stool examination, Liver function tests (LFTs), Kidney function tests (KFTs);Self-Rating Anxiety Scale (SAS);Self-Rating Depression Scale (SDS);Hospital Anxiety and Depression Scale (HADS);Hamilton Anxiety/Depression Scale (HAM-A/HAM-D);Anti-cyclic citrullinated peptide antibody (CCP);Rheumatoid Factor (RF);"Interleukin 4 (IL-4)";Interleukin 10 (IL-10);Interleukin-17 (IL-17);Secretory Immunoglobulin A (SIgA);5-hydroxytryptamine (5-HT);Dopamine (DA);cortisol;Phosphatidylinositol 3-kinase (PI3K);Protein Kinase B (AKT);Phospholipase C-? (PLC-?);Mitogen-activated protein kinase (MAPK);Protein Kinase C (PKC); | — |
Countries
China
Contacts
Public ContactAi Mei Pang
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed