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IRCT20151028024760N7 IRCT 2026-05-11 Mashhad University of Medical Sciences Effect of Nanomicellar Silymarin in Rheumatoid Arthritis Investigating the Effect of Nanomicellar Silymarin on Immunological Indicators in Patients with Rheumatoid Arthritis. 2026-09-21 anticipated 45 Recruiting https://irct.ir/trial/89964 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block randomization (stratified block randomization). Unit of randomization: Individual patient. Randomization strata: Patients will be stratified based on age (18-40 years and 41-60 years) and disease duration (1-1.5 years and 1.5-2 years) to ensure balance between groups. Tools used: The random sequence will be generated using www.randomization.com website with a table of random numbers. Block size of 4 will be used with 8 blocks total. How the random sequence will be built: A computer-generated random allocation sequence will be created by an independent statistician who will not be involved in patient enrollment or outcome assessment. Block sizes of 4 will be used to ensure equal allocation to three groups (intervention, placebo, control) with 15 patients per group. Allocation concealment: Yes, allocation concealment will be performed using sequentially numbered, opaque, sealed envelopes. The envelopes will be prepared by a person not involved in clinical assessments or data analysis. The randomization code will remain sealed and will be kept by this independent person until final data analysis is completed. The key to the code will not be accessible to patients, clinicians, or outcome assessors until the study is unblinded after final analysis, Blinding description: This is a triple-blind trial. Blinding will be implemented as follows: - Participants: Patients will not know their group allocation. Intervention and placebo capsules are identical in color, size, and packaging. - Principal investigator: The PI will be blinded and will not be involved in preparation or distribution of the study medications. - Healthcare providers: Routine care physicians (other than the outcome assessor) are not blinded because the intervention is an add-on to standard care. - Data collector: The person collecting blood samples and laboratory data will not know group allocation. - Outcome assessor: The rheumatologist performing clinical evaluations (DAS28-ESR, VAS) will be blinded to group assignment. - Data analyst: The statistician will receive a de-identified dataset with coded groups (e.g., A, B, C) and will remain blinded until all analyses are completed. - DSMB: Not applicable for this pilot trial. Blinding method: An independent person not involved in patient care, assessment, or analysis will prepare sequentially numbered, opaque, sealed envelopes containing the allocation code. This person will package and code the identical capsules. The allocation key will remain sealed until final data analysis. Emergency unblinding is possible according to protocol and will be documented. Blinding will be checked by asking blinded personnel about their guesses at the end of the study. 3 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. This study investigates the effect of nanomicellar silymarin as a potential adjunctive therapy in active RA patients.. 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).. No - There is not a plan to make this available Justification or reason for not sharing IPD is The current study protocol does not include a plan for public sharing of individual participant data (IPD). Summary results will be published in a peer-reviewed journal."
public Mojgan Mohammadi
Azadi Square, University Campus Complex, School of Medicine, Department of Immunology
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2376 MohammadiMZH@thums.ac.ir Mashhad University of Medical Sciences scientific Mojgan Mohammdi
Azadi Square, University Campus Complex, School of Medicine, Department of Immunology
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2376 MohammadiMZH@thums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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 M05 Rheumatoid arthritis with rheumatoid factor Treatment - Other 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). 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-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 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 Transforming Growth Factor-beta (TGF-β) 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-γ) 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. 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 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 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 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 ROR-γt 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. C-reactive protein (CRP). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Latex agglutination test. Rheumatoid factor (RF). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Latex agglutination test. Anti-cyclic citrullinated peptide (anti-CCP). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ELISA test. 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. Mashhad University of Medical Sciences Approved 2026-01-19 ٍEthics committee of Mashhad University of Medical Sciences Qoreishi Bulding, Daneshgah St Mashhad Razavi Khorasan Iran (Islamic Republic of)