Rheumatoid arthritis is a chronic autoimmune inflammatory disorder that primarily affects the synovial joints. It is characterized by progressive and symmetric joint inflammation, leading to cartilage destruction, bone erosion, and physical disability. The disease involves complex immunopathogenesis with key roles of inflammatory cytokines and T lymphocyte subsets. Despite available treatments including NSAIDs, glucocorticoids, and DMARDs, some patients show drug resistance or adverse effects. T
Conditions
Interventions
Group 1 (Intervention): Standard DMARDs regimen + Nanomicellar silymarin capsule (SinaLiv, Exir Nanosina Company) 70 mg, one capsule daily for 8 weeks.Group 2 (Placebo): Standard DMARDs regimen + Iden
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Active rheumatoid arthritis based on ACR/EULAR 2010 criteria with score of 6 or higher Age between 18 and 60 years At least one year and maximum two years have passed since disease diagnosis Receiving standard DMARDs regimen including Methotrexate up to 10 mg/week and Prednisolone up to 5 mg/day No prior use of biologic drugs
Exclusion criteria
Exclusion criteria: History of malignancy History of diabetes, chronic kidney disease or heart failure Pregnancy or breastfeeding Body mass index of 35 or higher Kellgren-Lawrence grade 4 or higher Unwillingness to continue participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the expression level of the Interleukin-22 (IL-22) gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interleukin-23 (IL-23) gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Transforming Growth Factor-beta (TGF-ß) gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the Interferon-gamma (IFN-?) gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the CCL2 gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the CCL5 gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the CXCL8 gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the NLRP3 gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the P2XR gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the BCMA gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Change in the expression level of the APRIL gene. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: SYBR Green-based real-time PCR assay.;Cha | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease activity score 28-joint count-erythrocyte sedimentation rate (DAS28-ESR). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Clinical and laboratory findings.;Visual analog scale (VAS) to assess the level of joint pain. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: The amount of pain that a patient feels. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMojgan Mohammadi
Mashhad University of Medical Sciences
Outcome results
None listed