The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Coronavirus Disease 2019 (COVID-19) (COVID-19)
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| ClinicalTrials.gov Identifier: NCT04981743 |
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Recruitment Status :
Recruiting
First Posted : July 29, 2021
Last Update Posted : July 29, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid19 | Dietary Supplement: Nigella Sativa capsule twice daily | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Controlled Parallel Open label Randomized Clinical Trial . |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Management of Coronavirus Disease 2019 (COVID-19) |
| Estimated Study Start Date : | July 21, 2021 |
| Estimated Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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).
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Active Comparator: group 2
Twenty five patients will be administered a single dose (900mg) of Nigella Sativa capsule twice daily plus standard therapy
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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 |
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Active Comparator: group 3
Twenty five patients will be administered a single dose (2000 IU) of vitamin D3 tablet once daily plus standard therapy
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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 |
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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.
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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 |
- 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
- 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 .
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with mild-moderate COVID-19 according to the classification (Table 1)
- Adult (18 - 65 years old).
- Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2.
Exclusion Criteria:
- Patients with severe illness requiring admission to intensive care unit.
- Asymptomatic patients.
- Severe chronic kidney disease (i.e. estimated glomerular filtration rate < 30 mL/min) or end stage renal disease requiring dialysis
- Severe chronic liver disease (Alanine transaminase or Aspartate transaminase > 5 times the upper limit of normal).
- contraindications to any of the interventional drugs.
- Pregnancy or breast feeding.
- Allergy to any of the interventional.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981743
| Contact: Amal A Elkholy | +201060355448 | amalanas9@gmail.com | |
| Contact: Shimaa A. Aly, Master | +201223844103 | shimaa.aly90@gmail.com |
| Egypt | |
| Respiratory System specialized hospital at Kobry Elobba Military Medical hospitals. | Recruiting |
| Cairo, Egypt, 012345 | |
| Contact: shimaa A. Aly, master +201223844103 shimaa.aly90@gmail.com | |
| Contact: Osama S. Beskales, Ass. Prof. +201223844103 shimaa.aly90@gmail.com | |
| Study Chair: | Nagwa A. Sabri, professor | Department of Clinical Pharmacy |
| Responsible Party: | Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT04981743 |
| Other Study ID Numbers: |
supplement therapy in COVID-19 |
| First Posted: | July 29, 2021 Key Record Dates |
| Last Update Posted: | July 29, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |