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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSO | Experimental | Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nigella sativa oil | Dietary Supplement | Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Days to Recovery | The number of days to recovery (number of symptomatic days) | Day 14 |
| Duration of Each Symptom | Duration of each symptom in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz University Hospital | Jeddah | 21589 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34407441 | Derived | Koshak AE, Koshak EA, Mobeireek AF, Badawi MA, Wali SO, Malibary HM, Atwah AF, Alhamdan MM, Almalki RA, Madani TA. Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial. Complement Ther Med. 2021 Sep;61:102769. doi: 10.1016/j.ctim.2021.102769. Epub 2021 Aug 15. | |
| 32771034 | Derived |
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233 cases assessed for eligibility. 50 cases were excluded because; Asymptomatic (31), Pregnant (3), Declined to participate (n= 7), Failed communication (n= 9)
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard of care |
| FG001 | Nigella Sativa Oil | Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nigella Sativa Oil | Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days |
| BG001 | Control | Standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | Day 14 |
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nigella Sativa Oil | Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abdulrahman Koshak | King Abdulaziz University | 0543292333 | aekoshak@kau.edu.sa |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2020 | May 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
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Prospective, randomized, open-label, controlled clinical study
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| Day 14 |
| Side Effects | Side effects from the investigational treatment | Day 14 |
| Hospital Admission Due to Disease Complications | High severity of COVID-19 (mild cases does not require hospitalization) | Day 14 |
| Koshak AE, Koshak EA, Mobeireek AF, Badawi MA, Wali SO, Malibary HM, Atwah AF, Alhamdan MM, Almalki RA, Madani TA. Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial. Trials. 2020 Aug 8;21(1):703. doi: 10.1186/s13063-020-04647-x. |
| Hospitalized |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoker | Count of Participants | Participants |
|
| Pre-enrollment days | The time from the first day of symptoms until the day of enrollment | Mean | Standard Deviation | days |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | The Number of Days to Recovery | The number of days to recovery (number of symptomatic days) | Posted | Median | Inter-Quartile Range | days | Day 14 |
|
|
|
| Secondary | Duration of Each Symptom | Duration of each symptom in days | Posted | Mean | Standard Deviation | days | Day 14 |
|
|
|
| Secondary | Side Effects | Side effects from the investigational treatment | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| Secondary | Hospital Admission Due to Disease Complications | High severity of COVID-19 (mild cases does not require hospitalization) | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 3 |
| 87 |
| EG001 | Control | Standard of care | 0 | 86 | 0 | 86 | 0 | 86 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Loss of appetite |
|
| Chills |
|