A study of the effect of Nigella Sativa oil on control of disease activity and serum levels of IL-10, TNF-α, and oxidative stress markers in patients with Behcet's disease

Objectives: The aim of this study is the comparison of the effect of oral administration of Nigella Sativa oil (NSO) and placebo on disease activity and serum levels of oxidative stress markers, and IL-10 and TNF-α cytokines in Behcet’s disease (BD). Design, setting and conduct: In a randomized double blind study in Connective Tissue Diseases Research Center of Tabriz University of Medical Sciences, 88 patients with BD will recruit to the study. They will divide randomly to the case and control groups. Disease activity of patients will be measured by the Iranian’s Behcet’s disease activity measure (IBDDAM). Participants: Patients with BD. Inclusion criteria: age > 16; having active BD (IBDDAM > 2.5). Exclusion criteria: consumption of NSO supplements in the past 8 weeks; pregnancy and lactation; Liver disease; renal insufficiency. Intervention: case group will receive soft gels containing 1000 mg NSO per day and another group will receive soft gels containing 1000 mg placebo per day. Soft gels containing NSO oil and placebo will be manufactured by the Barij Essence Pharmaceutical Company. All patients will be visited before intervention and every 2 months for 6 months. Before intervention and 2 months after that 10 milliliter blood samples will be taken, centrifuged, and stored at the -70 ºC. Plasma levels of TNF-α, IL-10, oxidant and antioxidant systems (total antioxidant, malondialdehyde) will be measured at the end of study. Main outcome measures are disease activity which will be measured by the IBDDAM and plasma levels of TNF-α, IL-10, oxidant and antioxidant systems.

Vice chancellor for research, Tabriz University of Medical Sciences