The aim of this study was to evaluate the effects of Nigella sativa (N. sativa) in addition to quadruple‐therapy on Helicobacter pylori eradication, dyspepsia, biochemical‐markers, and quality of life in infected patients. In this double‐blind placebo‐controlled clinical‐trial, 51 H. pylori infected patients with functional dyspepsia were randomly assigned to treatment (quadruple‐therapy with 2 g/day N. sativa) or placebo groups (quadruple‐therapy with 2 g/day placebo) for 8 weeks. Serum levels of interleukin‐8 (IL‐8), high‐sensitivity C‐reactive protein (hs‐CRP) and malondialdehyde, quality of life, dyspepsia, food‐intake, body‐weight, and body mass index (BMI) were evaluated at the baseline and at the end of the study. H. pylori eradication was evaluated at the end of the intervention. At the end of the study, H. pylori eradication was more in the N. sativa group compared with the placebo (p = .01). Weight, BMI, and dietary‐intake (p < .05) increased significantly as compared with placebo. A significant improvement was also observed in patients' quality of life in the treatment group compared with the placebo (p < .05). The differences of biochemical‐markers and dyspepsia between the two groups were not significant. So, N. sativa supplementation with medical treatment may have beneficial effects on H. pylori eradication, weight, BMI, dietary‐intake, and quality of life in infected patients.

Objective This double-blind, placebo-controlled, clinical trial was conducted to define the effects of Nigella sativa (N. Sativa) powder plus conventional medical treatment of Helicobacter pylori (H. pylori) on serum ghrelin level and appetite in H. pylori-infected patients. Methods In the present study, 51 H. pylori-positive patients were randomly allocated to treatment (n = 26) or placebo (n = 25) groups. They received 2 g/day N. Sativa with quadruple therapy or 2 g/day placebo plus quadruple therapy for 8 weeks. The serum level of ghrelin was assessed before and after the intervention. Appetite was evaluated at the onset and at the end of the intervention. Results At the end of the study, the appetite of the treatment group improved significantly compared with the placebo group (P = 0.02). Statistically, the difference in serum ghrelin levels between the study’s groups was insignificant (P > 0.05). Conclusion Supplementation with N. Sativa powder may be a beneficial adjunctive therapy in H. pylori-infected patients. Trial registration This study was registered in the Iranian Registry of Clinical Trials (IRCT20170916036204N7) on 08/08/2018.