Potential benefits of Nigella sativa oil supplementation on asthma inflammation: a randomised, double-blind, placebo-controlled, exploratory phase-II clinical trial

Abstract

Long‐term medications in patients with asthma are needed to control the underlying inflammation and prevent symptoms.However, Asthma control is considered to be suboptimal regardless of the availability of conventional treatments.Traditionally, Nigella sativa L. (NS), known as black cumin seed, is thought to be effective in treating asthma or its keysymptoms. Our aim is to investigate the benefits of NS supplementation on clinical and inflammatory parameters ofbronchial asthma in patients on standard therapy. A chemically characterised NS oil product (Marnys®) marketed as a foodsupplement was used in a randomised, double‐blind, placebo‐controlled, phase II trial (RDBPCT) with asthma patients. Theprimary outcome was the Asthma Control Test (ACT). The secondary outcomes were lung function (predicted FEV1%),blood eosinophils, serum total Immunoglobulin E (IgE), and multiple inflammatory mediators. Statistical independent t‐testand Mann‐Whitney U tests were used. The trial was registered with clinicaltrials.gov, identifier NCT02407262. Between Jun1 and Dec 30, 2015, 80 patients were enrolled, with 40 patients each randomly assigned to treatment and placebo groups.After 4 weeks, 10 patients had withdrawn from each group. NS showed a statistically significant improvement in ACT andblood eosinophils count. NS showed non‐significant elevation of predicted FEV1%. Changes in INF‐gamma, IL‐10, and IL‐12p70 were noteworthy between both groups. NS appeared to improve asthma symptoms, and some asthma‐relatedbiomarkers. Future studies should follow patients for a longer period and validate outcomes using different approaches.