ABSTRACT
Introduction: Effective treatment for patients with the novel Coronavirus Disease (COVID-19) is desperately needed and is under rigorous research. Nigella sativa oil (NSO), a herbal medicine, that has a documented wide antiviral and immunomodulatory activities offering a therapeutic potential for COVID-19. Methods: Adult symptomatic patients with mild COVID-19 were recruited between May and August 2020 from King Abdulaziz University Hospital in Jeddah, Saudi Arabia. They were randomly assigned to receive supplementation with oral capsules of NSO (MARNYS' Cuminmar 500 mg twice daily for 10 days) plus standard of care or standard of care medications alone. The primary endpoint was the proportion of patients recovered (free of symptoms for 3 days) within 14 days after randomization. This trial was registered with clinicaltrials.gov, NCT04401202. Results: A total of 120 patients were enrolled. Their mean age was 35 (SD=11) years old and 57% of them were male. There were 60 patients in the treatment group (NSO) and 60 patients in the control group. The proportion of patients recovered in the treatment group was significantly higher than the control group, 42 (70%) versus 27 (45%) (p=0.006). Additionally, there was a significant difference in the average recovery time among both groups, 9.9 (SD=3.3) versus 11.6 (SD=3.4) days (p=0.006). Furthermore, 3 patients from the control group required hospitalization within the study period versus one in the treatment group. Adverse events were reported in 3 patients of NSO recipients as gastrointestinal symptoms. Conclusion: In this RCT of adult patients with mild COVID-19, NSO was associated with a significant increase in the likelihood of recovery and a decrease in the likelihood of hospitalization. To our knowledge, this is the first RCT that shows potential therapeutic benefits of NSO in patients with COVID-19 which requires further confirmation with larger double-blinded RCTs. Keywords: Black seed, Nigella sativa, COVID-19, SARS-CoV-2;randomized controlled trial