The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Coronavirus Disease 2019 (COVID-19) (COVID-19)

July 27, 2021 updated by: Ain Shams University

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

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 012345
        • Recruiting
        • Respiratory System specialized hospital at Kobry Elobba Military Medical hospitals.
        • Contact:
        • Contact:

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: group 1
Twenty five patients will be administered only the standard treatment regimen according to Ministry Of Health, and Population management protocol for COVID-19 patients (November 2020).
ACTIVE_COMPARATOR: group 2
Twenty five patients will be administered a single dose (900mg) of Nigella Sativa capsule twice daily plus standard therapy
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 Names:
  • single dose of vitamin D3 tablet (2000 IU) once daily
ACTIVE_COMPARATOR: group 3
Twenty five patients will be administered a single dose (2000 IU) of vitamin D3 tablet once daily plus standard therapy
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 Names:
  • single dose of vitamin D3 tablet (2000 IU) once daily
ACTIVE_COMPARATOR: group 4
Twenty five patients will be administered a single dose (900 mg) of Nigella Sativa capsule twice daily, and single dose of vitamin D3 tablet (2000 IU) once daily plus standard therapy.
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 Names:
  • single dose of vitamin D3 tablet (2000 IU) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety and efficacy of Nigella Sativa and Vitamin D3 as a supplement for management of COVID-19 will be evaluated and recorded.
Time Frame: baseline and 14 days

The patient will be examined by the physician and the rate of occurrence of any of the following signs and symptoms on the participants will be reported:

  • Fever -Runny nose - Red swollen eyes
  • Fatigue - Shortening in breath - Skin rash
  • Cough - Body aches
  • Sore throat - Diarrhea, and/or Vomiting
  • Headache - Loss of taste and/or Smell
baseline and 14 days
Assessment of patient health status before and after treatment intervention for a period of 14 days will be done
Time Frame: baseline and 14 days

All patients will be evaluated during the study period (14 days) by undergoing PCR test after two days from absence of any clinical presentation, Then if the PCR is negative, the patient will be discharged from the hospital and complete his medication course at home.

  • If the result is positive then the patient will undergo another PCR testing on day 14 with no further follow up .
baseline and 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recovery rate of patients, Intensive care unit admission rate of patients and the Length of hospital stay of the patients will be recorded
Time Frame: 14 days
Length of hospital stay and number of patients need ICU admission due to deterioration of cases and progression of disease.
14 days
The following laboratory testing will be performed at least twice during the study period:
Time Frame: 14 days
  • C-Reactive Protein in mg/L.
  • Arterial Blood Gases[carbon dioxide partial pressure, oxygen partial pressure] in mm Hg.
  • Kidney function [serum creatinine, blood urea nitrogen ] in mg/dL.
  • liver function [ Alanine aminotransferase, Aspartate aminotransferase] in IU/L .
  • Erythrocyte sedimentation rate in mm/hr.
  • Complete blood picture.
  • Serum Ferritin in ug/L
  • international normalized ratio, prothrombin time, partial thromboplastin time in seconds
  • Polymerase chain reaction (PCR).
  • Computed tomography (CT) chest .

Length of hospital stay and number of patients need ICU admission due to deterioration of cases and progression of disease.
14 days

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Chair: Nagwa A. Sabri, Professor, Department of Clinical Pharmacy

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 (ANTICIPATED)

July 21, 2021

Primary Completion (ANTICIPATED)

September 30, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (ACTUAL)

July 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • supplement therapy in COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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