Back to resultsNigella Sativa in COVID-19
Primary Purpose
COVID-19, SARS-CoV-2
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Nigella sativa oil
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Nigella sativa, Herbal
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.
Sites / Locations
- King Abdulaziz University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NSO
Control
Arm Description
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Standard of care
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
The Number of Days to Recovery
The number of days to recovery (number of symptomatic days)
Duration of Each Symptom
Duration of each symptom in days
Side Effects
Side effects from the investigational treatment
Hospital Admission Due to Disease Complications
High severity of COVID-19 (mild cases does not require hospitalization)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04401202
Brief Title
Nigella Sativa in COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
COVID-19, SARS-CoV-2, Nigella sativa, Herbal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, open-label, controlled clinical study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NSO
Arm Type
Experimental
Arm Description
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Nigella sativa oil
Intervention Description
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
Description
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
Secondary Outcome Measure Information:
Title
The Number of Days to Recovery
Description
The number of days to recovery (number of symptomatic days)
Time Frame
Day 14
Title
Duration of Each Symptom
Description
Duration of each symptom in days
Time Frame
Day 14
Title
Side Effects
Description
Side effects from the investigational treatment
Time Frame
Day 14
Title
Hospital Admission Due to Disease Complications
Description
High severity of COVID-19 (mild cases does not require hospitalization)
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
King Abdulaziz University Hospital
City
Jeddah
ZIP/Postal Code
21589
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34407441
Citation
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.
Results Reference
derived
PubMed Identifier
32771034
Citation
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.
Results Reference
derived
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Nigella Sativa in COVID-19
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