The efficacy of Nigella sativa L. oil on serum biomarkers of inflammation and oxidative stress and quality of life in patients with knee osteoarthritis: A parallel triple-arm double-blind randomized controlled trial.

The aim of this double-blind clinical trial was to investigate the effects of Nigella sativa oil on serum inflammatory and oxidative stress biomarkers and quality of life in patients with knee osteoarthritis (OA). Forty-five patients who met the eligibility criteria were randomly divided into three groups with a ratio of 1:1:1. The first group received 2.5 mL oral N. sativa oil twice/day plus placebo topical oil, the second group received 2.5 mL topical N. sativa oil three times/day plus placebo oral oil, and the third group received oral and topical oil placebos. There were no intergroup differences in baseline characteristics. After 6 weeks of supplementation, oral N. sativa caused a significant improvement in the serum levels of hs-CRP ( p  = .003), MDA ( p  = .003), and TAC ( p  = .001). Oral N. sativa oil compared to placebo (aMD (95% CI): -0.81 (-1.45 to -0.19); p  = .012) and topical N. sativa oil [aMD (95% CI): -0.76 (-1.38 to -0.15); p  = .016] significantly reduced hs-CRP serum levels. Significant improvements were observed in the general, physical, and mental health subscales in the oral and topical N. sativa oil compared to the placebo group ( p  < .05). The six-week oral N. sativa oil supplementation was effective in improving inflammatory biomarkers in knee OA. Both oral and topical N. sativa oil increased the quality of life.