Nigella Sativa in COVID-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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Conditions

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COVID-19 SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, open-label, controlled clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NSO

Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Group Type EXPERIMENTAL

Nigella sativa oil

Intervention Type DIETARY_SUPPLEMENT

Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Control

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nigella sativa oil

Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No