Nigella Sativa in COVID-19
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
1 other identifier
interventional
183
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedStudy Start
First participant enrolled
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
May 26, 2021
CompletedMay 26, 2021
May 1, 2021
7 months
May 21, 2020
May 23, 2021
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
The Number of Days to Recovery
Day 14
Duration of Each Symptom
Day 14
Side Effects
Day 14
Hospital Admission Due to Disease Complications
Day 14
Study Arms (2)
NSO
EXPERIMENTALNigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Control
NO INTERVENTIONStandard of care
Interventions
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdulaziz University Hospital
Jeddah, 21589, Saudi Arabia
Related Publications (2)
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.
PMID: 34407441DERIVEDKoshak 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.
PMID: 32771034DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Abdulrahman Koshak
- Organization
- King Abdulaziz University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 21, 2020
First Posted
May 26, 2020
Study Start
May 21, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
May 26, 2021
Results First Posted
May 26, 2021
Record last verified: 2021-05