Official Title
Evaluation of The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Management of Coronavirus Disease 2019 (COVID-19)
Brief Summary

The aim this study is to investigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 .

Detailed Description

Corona-virus disease-19 (COVID-19) is caused by the severe acute respiratory syndrome
coronavirus 2, and this virus was first originated from Wuhan city of Hubei province of China
spreading around the globe. The prominent symptoms of COVID-19 include fever, cough, dyspnea,
and other symptoms noted in patients affected by COVID-19 that includes; chills, repeated
shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell. In
addition, the emergency warning signs of COVID-19 include difficulty breathing or shortness
of breath, persistent pain or pressure in the chest, new confusion or inability to arouse and
bluish lips or face and the patients experiencing any of these signs should get immediate
medical attention.

Herbal medicines are used by many people to try to improve their health upon the believe that
"natural products" are always safe, and good for immunity based on the traditional knowledge
.There is a potential of Nigella Sativa to treat the patients with COVID-19.

Nigella Sativa (NS), a widely used medicinal plant of the family Ranunculaceae ; commonly
known as Black Cumin, has been shown to exert antiviral effects against a variety of viruses
such as Mouse Cytomegalovirus and Hepatitis C Virus (HCV) . The components' antimicrobial
properties against various microbes as well as their anti-inflammatory and immuno-modulatory
effects have also been established .

The immune system defends the body from foreign, invading organisms, promoting protective
immunity, while maintaining tolerance to self. The implications of vitamin deficiency on the
immune system have become clearer in recent years, and in the context of vitamin D
deficiency, the increased susceptibility to infection observed, especially in a genetically
susceptible host to autoimmunity.

The classical actions of vitamin D are to promote calcium homeostasis, and to promote bone
health. In humans, vitamin D is obtained from the diet, or synthesized in the skin as vitamin
D is cutaneously produced after exposure to UV light, its synthesis is influenced by
latitude, season, use of sun-block and skin pigmentation. Melanin absorbs UV radiation
inhibiting the synthesis of vitamin D from 7-dihydrocholesterol. This initial vitamin D
compound is inactive form; hydroxylation in the liver to form the active 25 hydroxy vitamin
D3 (25 D). Vitamin D is the most reliable measurement of an individual's vitamin D status. It
is converted in the kidney to the active compound 1,25 dihydroxy vitamin D (1,25 D) or
calcidiol by 1-α-hydroxylase (CYP27B1), an enzyme which is stimulated by parathormone.

A principal defense against uncontrolled inflammation, and against viral infection in
general, is provided by T regulatory lymphocytes (Tregs). Treg levels have been reported to
be low in many COVID-19 patients, and can be increased by vitamin D supplementation. Low
vitamin D levels have been associated with an increase in inflammatory cytokines, and a
significantly increased risk of pneumonia, and viral upper respiratory tract infections.

Unknown status
COVID19

Dietary Supplement: Nigella Sativa capsule twice daily

investigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 .
Other Name: single dose of vitamin D3 tablet (2000 IU) once daily

Eligibility Criteria

Inclusion Criteria:

1. Patients with mild-moderate COVID-19 according to the classification (Table 1)

2. Adult (18 - 65 years old).

3. Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory
Syndrome Coronavirus-2.

Exclusion Criteria:

1. Patients with severe illness requiring admission to intensive care unit.

2. Asymptomatic patients.

3. Severe chronic kidney disease (i.e. estimated glomerular filtration rate < 30 mL/min)
or end stage renal disease requiring dialysis

4. Severe chronic liver disease (Alanine transaminase or Aspartate transaminase > 5 times
the upper limit of normal).

5. contraindications to any of the interventional drugs.

6. Pregnancy or breast feeding.

7. Allergy to any of the interventional.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Egypt
Locations

Respiratory System specialized hospital at Kobry Elobba Military Medical hospitals.
Cairo, Egypt

Investigator: shimaa A. Aly, master
Contact: +201223844103
shimaa.aly90@gmail.com

Contacts

Amal A Elkholy
+201060355448
amalanas9@gmail.com

Shimaa A. Aly, Master
+201223844103
shimaa.aly90@gmail.com

Nagwa A. Sabri, professor, Study Chair
Department of Clinical Pharmacy

Ain Shams University
NCT Number
MeSH Terms
COVID-19
Vitamin D