Effect of Nigella sativa oil extracts on inflammatory and oxidative stress markers in Behcet's disease: A randomized, double-blind, placebo-controlled clinical trial

Objective: Behcet's disease (BD) is a chronic inflammatory disorder characterized by recurrent oral and genital aphthous ulcers, uveitis and skin lesions. Oxidative stress and inflammation have important role in the pathogenesis of BD. The aim of this study was to assess the effect of Nigella sativa (NS) oil administration on malondialdehyde (MDA), total anti-oxidant capacity (TAC), tumor necrosis factor-alpha (TNF-alpha), IL-10 and high sensitivity C-reactive protein (hs- CRP) levels in patients with BD. Materials and Methods: In this randomized, double-blind and placebo-controlled clinical trial, 96 BD patients were randomly assigned to NS or placebo groups. Study groups received 1000 mg/day NS oil and placebo soft gels for 8 weeks. Serum levels of TNF-alpha, IL-10, hs-CRP, MDA and TAC were measured before and after treatment. Results: Eighty-nine individuals completed the study. Significant decreases in the serum levels of MDA and increases in the serum levels of TAC were found in the NS group. However, differences in the changes of MDA and TAC in the NS and placebo groups were not significant. Pre- and post-intervention changes of TNF-alpha, IL-10 and hs-CRP levels in the NS group were non-significant. Conclusion: NS 1000 mg per day is probably not effective in reducing the inflammatory and oxidative markers in BD.