Nigella Sativa in COVID-19

May 25, 2021 updated by: Dr Abdulrahman E. Koshak, King Abdulaziz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21589
        • King AbdulAziz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSO
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Dietary supplement: Nigella sativa oil
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
No Intervention: Control
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
Time Frame: Day 14
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Days to Recovery
Time Frame: Day 14
The number of days to recovery (number of symptomatic days)
Day 14
Duration of Each Symptom
Time Frame: Day 14
Duration of each symptom in days
Day 14
Side Effects
Time Frame: Day 14
Side effects from the investigational treatment
Day 14
Hospital Admission Due to Disease Complications
Time Frame: Day 14
High severity of COVID-19 (mild cases does not require hospitalization)
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 266-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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