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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | No Intervention | 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). | |
| group 2 | Active Comparator | Twenty five patients will be administered a single dose (900mg) of Nigella Sativa capsule twice daily plus standard therapy |
|
| group 3 | Active Comparator | Twenty five patients will be administered a single dose (2000 IU) of vitamin D3 tablet once daily plus standard therapy |
|
| group 4 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nigella Sativa capsule twice daily | Dietary Supplement | investigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 . |
| 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. | 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:
| baseline and 14 days |
| Assessment of patient health status before and after treatment intervention for a period of 14 days will be done | 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.
| baseline and 14 days |
| 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 | 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: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal A Elkholy | Contact | +201060355448 | amalanas9@gmail.com | |
| Shimaa A. Aly, Master | Contact | +201223844103 | shimaa.aly90@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nagwa A. Sabri, professor | Department of Clinical Pharmacy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory System specialized hospital at Kobry Elobba Military Medical hospitals. | Recruiting | Cairo | 012345 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31986264 | Background | Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. | |
| 32179124 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Controlled Parallel Open label Randomized Clinical Trial .
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|
Length of hospital stay and number of patients need ICU admission due to deterioration of cases and progression of disease. |
| 14 days |
| Background |
| Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13. |
| 32322478 | Background | Horowitz RI, Freeman PR, Bruzzese J. Efficacy of glutathione therapy in relieving dyspnea associated with COVID-19 pneumonia: A report of 2 cases. Respir Med Case Rep. 2020 Apr 21;30:101063. doi: 10.1016/j.rmcr.2020.101063. eCollection 2020. |
| 32269670 | Background | Montero-Odasso M, Goens SD, Kamkar N, Lam R, Madden K, Molnar F, Speechley M, Stranges S. Canadian Geriatrics Society COVID-19 Recommendations for Older Adults. What Do Older Adults Need To Know? Can Geriatr J. 2020 Mar 1;23(1):149-151. doi: 10.5770/cgj.23.443. eCollection 2020 Mar. No abstract available. |
| 36425571 | Derived | Said SA, Abdulbaset A, El-Kholy AA, Besckales O, Sabri NA. The effect of Ni gella sativa and vitamin D3 supplementation on the clinical outcome in COVID-19 patients: A randomized controlled clinical trial. Front Pharmacol. 2022 Nov 8;13:1011522. doi: 10.3389/fphar.2022.1011522. eCollection 2022. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |