Effect of Nanomicellar Silymarin in Rheumatoid Arthritis

INTERVENTION: 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 + Identical placebo capsule (gelatin capsule containing corn starch), one capsule daily for 8 weeks.Group 3 (Control): Standard DMARDs regimen only (no additional intervention).. CONDITION: 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 comple Ximmunopathogenesis 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. This study investigates the effect of nanomicellar silymarin as a potential adjunctive therapy in active RA patients.. ; Rheumatoid arthritis with rheumatoid factor PRIMARY OUTCOME: Anti‐cyclic citrullinated peptide (anti‐CCP). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA test. C‐reactive protein (CRP). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Latex agglutination test. 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. Change in the expression level of the BAFF 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 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 FOXP3 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 GATA3 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 Interleukin‐1 (IL‐1) 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‐10 (IL‐10) 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‐17 (IL‐17) 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‐18 (IL‐18) 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‐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 Interleukin‐4 (IL‐4) 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 ROR‐?t 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 T‐bet 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 TACI 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. Rheumatoid factor (RF). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Latex agglutination test. SECONDARY OUTCOME: 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. 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