A Phase 2 interventional study of Nigella sativa oil in COVID-19 and SARS-CoV-2, sponsored by King Abdulaziz University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by King Abdulaziz University · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 183 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →King Abdulaziz University is the lead sponsor of 96 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Dietary Supplement: Nigella sativa oil
Standard of care
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)
Time frame: Day 14
The Number of Days to Recovery
The number of days to recovery (number of symptomatic days)
Time frame: Day 14
Duration of Each Symptom
Duration of each symptom in days
Time frame: Day 14
Side Effects
Side effects from the investigational treatment
Time frame: Day 14
Hospital Admission Due to Disease Complications
High severity of COVID-19 (mild cases does not require hospitalization)
Time frame: Day 14
| Milestone | Control | Nigella Sativa Oil |
|---|---|---|
| Started | 92 | 91 |
| Completed | 86 | 87 |
| Not completed | 6 | 4 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Hospitalized | 4 | 1 |
The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)
| Participants | Nigella Sativa Oil | Control |
|---|---|---|
| Percentage of Participants With Clinical Recovery Within 14 Days After Randomization | 54 | 31 |
The number of days to recovery (number of symptomatic days)
| days | Nigella Sativa Oil | Control |
|---|---|---|
| The Number of Days to Recovery | 11 (8 to 14) | 14 (11 to 14) |
Duration of each symptom in days
| days | Nigella Sativa Oil | Control |
|---|---|---|
| Anosmia | 8.5 ± 3.9 | 10.4 ± 3.6 |
| Runny nose | 2.5 ± 1.6 | 3.7 ± 2.5 |
| Loss of appetite | 3.5 ± 2.9 | 5.5 ± 3.1 |
| Chills | 2.1 ± 1 | 4.9 ± 3.4 |
Side effects from the investigational treatment
| Participants | Nigella Sativa Oil | Control |
|---|---|---|
| Side Effects | 3 | 0 |
High severity of COVID-19 (mild cases does not require hospitalization)
| Participants | Nigella Sativa Oil | Control |
|---|---|---|
| Hospital Admission Due to Disease Complications | 0 | 4 |
Collected over 14 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nigella Sativa Oil | 0/87 (0%) | 0/87 (0%) | 3/87 (3.4%) |
| Control | 0/86 (0%) | 0/86 (0%) | 0/86 (0%) |
| Event | Nigella Sativa Oil | Control |
|---|---|---|
| Gastrointestinal symptomsGastrointestinal disorders | 3/87 | 0/86 |
| Age, Continuous(years) | Nigella Sativa Oil | Control | Total |
|---|---|---|---|
| Mean | 35 ± 10 | 35 ± 11 | 35 ± 11 |
| Sex: Female, Male(Participants) | Nigella Sativa Oil | Control | Total |
|---|---|---|---|
| Female | 41 | 39 | 80 |
| Male | 46 | 47 | 93 |
| Race and Ethnicity Not Collected(Participants) | Nigella Sativa Oil | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI(kg/m^2) | Nigella Sativa Oil | Control | Total |
|---|---|---|---|
| Mean | 27.1 ± 6.1 | 27.2 ± 5.5 | 27.1 ± 5.7 |
| Smoker(Participants) | Nigella Sativa Oil | Control | Total |
|---|---|---|---|
| Count of participants | 12 | 9 | 21 |
| Pre-enrollment days(days) | Nigella Sativa Oil | Control | Total |
|---|---|---|---|
| Mean | 3.5 ± 2.1 | 4 ± 3.1 | 3.7 ± 2.6 |
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King Abdulaziz University