» Advanced search
Only first 10,000 results will be saved in the file.
No item is selected. Use checkboxes to select search results.
Displaying 1-1 of 1 results.
 
{{ selectedCountPage }} items selected on this page, {{ selectedCountPage }} item selected on this page, {{ selectedCountTotal }} item in total {{ selectedCountTotal }} items in total
Study aim: Evaluating effect of nanomicellar silymarin on clinical and immunological indicators in rheumatoid arthritis Design: A randomized, triple-blind, superiority, parallel group trial with three arms (intervention, placebo, control). Sample size: 45 patients (15 per group). Randomization: block randomization (block size 4) using computer-generated random sequence from www.randomization.com with allocation concealment by sequentially numbered, opaque, sealed envelopes. Single center (Ghaem Hospital, Mashhad, Iran). Phase 3. Settings and conduct: Single-center trial in Mashhad. 45 RA patients randomized to 3 groups: silymarin+DMARDs, placebo+DMARDs, DMARDs alone. 8 weeks. Triple-blind (patient, assessor, analyst). Independent person seals allocation. Participants/Inclusion and exclusion criteria: Inclusion: Active RA (ACR/EULAR 2010, score≥6); age 18-60y; disease duration 1-2y; on standard DMARDs (MTX≤10mg/wk + prednisolone≤5mg/d); no biologics. Exclusion: Malignancy; diabetes/CKD/heart failure; pregnancy/breastfeeding; BMI≥35; K/L grade≥4; unwillingness. Intervention groups: Group1 (Intervention): Standard DMARDs + nanomicellar silymarin (SinaLiv) 70mg, 1 cap/day, 8 weeks. Group 2 (Placebo): Standard DMARDs + identical placebo (gelatin capsule with corn starch), 1 cap/day, 8 weeks. Group 3 (Control): Standard DMARDs only. Main outcome variables: Primary outcomes (measured at baseline and week 8): 1. Gene expression changes of 22 immune-related genes including IL-1, IL-4, IL-10, IL-17, IL-18, IL-22, IL-23, TGF-β, IFN-γ, CCL2, CCL5, CXCL8, NLRP3, P2XR, BCMA, APRIL, TACI, BAFF, T-bet, GATA3, ROR-γt, and FOXP3 measured by real-time PCR. 2. Serum levels of CRP, RF, and Anti-CCP. Secondary outcomes (measured at baseline and week 8): 1. DAS28-ESR score (clinical disease activity index). 2. VAS score (pain assessment).
IRCTID: IRCT20151028024760N7
  1. Evaluation of the effects of supplementation extract prepared from Capparis spinosa on clinical manifestations, para-clinical and immunological factors in patients with refractory rheumatoid arthritis.
  2. Evaluation of the Effects of Nanomicellar Curcumin Supplementation on Inflammatory Markers and Quality of Life in Patients with ANCA-Associated Vasculitis: A Randomized Controlled Clinical Trial
  3. Evaluation the Effect of N-acetylcysteine on Inflammatory Biomarkers and Disease Activity Score (DAS28-ESR) of Rheumatoid Arthritis
  4. Investigation of the effect of azithromycin on disease activity in rheumatoid arthritis patients
  5. Evaluation of Mesenchymal stem cell therapy effects on the cellular immune response in refractory rheumatoid arthritis patients
  6. Comparison of the efficiency of nanomicellar formulation with standard formulation of fat-soluble vitamins in patients with cystic fibrosis
  7. The effect of Bromelain supplementation alone and in combination with Curcumin on disease symptoms and severity, inflammatory markers and oxidative stress in patients with Rheumatoid Arthritis
  8. Evaluating the effects of oral N-acetyl cysteine as a Adjuvant therapy on controling clinical symtoms and serum level of inflammatory biomarkers including IL6,TNF-α, CRP and ESR in rhumatoid arthritis Patients
  9. The effects of probiotic supplementation on disease activity and inflammatory biomarkers of women with rheumatoid arthritis: a randomized controlled trial
  10. Effect of Silybum marianum on methotrexate-induced hepatotoxicity and its analgesic effect in the patients with rheumatoid arthritis history
Loading...