title: Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial.
abstract: OBJECTIVE
  Nigella sativa is a medicinal plant that has long been used in traditional medicine for treating various conditions. Numerous animal studies provided evidences that the seed may elicit a broad anti-inflammatory/anti-oxidant activity. The aim of the present clinical trial was to evaluate anti-inflammatory and antioxidant properties of Nigella sativa oil in patients with rheumatoid arthritis (RA).
  
  
  METHODS
  Forty-two patients with RA were assigned into two groups in this randomized, double blind, placebo-controlled clinical trial. Subjects in intervention group received two capsules, 500 mg each, of Nigella sativa oil, each day for 8 weeks. The other group consumed two capsules as placebo per day for the same period of time. Serum TNF-α, IL-10, and whole blood levels of oxidative stress parameters were measured at baseline and end of the trial.
  
  
  RESULTS
  The serum level of IL-10 was increased in the Nigella sativa group (p<0.01). Moreover, treatment with Nigella sativa led to significant reduction of serum MDA and NO compared with baseline (p<0.05). There were no significant differences in the TNF-α, SOD, catalase, and TAS values between or within the groups, before and after the intervention (p>0.05).
  
  
  CONCLUSIONS
  This study indicates that Nigella sativa could improve inflammation and reduce oxidative stress in patients with RA. It is suggested that Nigella sativa may be a beneficial adjunct therapy in this population of patients.
authors.affiliation: Department of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Vahid
authors.initials: V
authors.lastname: Hadi
authors.affiliation: Department of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Sorayya
authors.initials: S
authors.lastname: Kheirouri
authors.affiliation: Department of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Alizadeh
authors.affiliation: Department of Internal Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Alireza
authors.initials: A
authors.lastname: Khabbazi
authors.affiliation: Department of Agriculture, Barij Essence Pharmaceutical Company , Kashan, Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Hosseini
keywords: IL-10; Nigella sativa; Oxidative stress; Rheumatoid arthritis; TNF-α