Official Title
Effects of Nigella Sativa as a Treatment of Patients With Upper Respiratory Tract Infection Caused by SARS-coronavirus-2: a Prospective, Randomized, Open-label, Controlled Clinical Study
Brief Summary

Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.

Completed
COVID-19
SARS-CoV-2

Dietary Supplement: Nigella sativa oil

Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Eligibility Criteria

Inclusion Criteria:

- Patients with mild COVID19 upper respiratory tract infection and with no evidence of
pneumonia

- Adult (18 Years and above)

- Written informed consent prior to initiation of any study procedures by the patient
(or legally authorized representative).

- Understands and agrees to comply with planned study procedures.

- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by
polymerase chain reaction (PCR) available at KAUH.

Exclusion Criteria:

- Patients with pneumonia or severe illness requiring admission to ICU.

- Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) < 30)
or end stage renal disease requiring dialysis

- Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) > 5
times the upper limit of normal).

- Pregnancy or breast feeding.

- Anticipated transfer to another hospital which is not a study site within 72 hours.

- Allergy to any study medication.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Saudi Arabia
Locations

King Abdulaziz University Hospital
Jeddah, Saudi Arabia

King Abdulaziz University
NCT Number
Keywords
Covid-19
SARS-CoV-2
Nigella Sativa
Herbal
MeSH Terms
COVID-19