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

NCT04981743 | Unknown

• 1 other identifier: supplement therapy in COVID-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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: * 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

  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 Outcomes (2)

• The recovery rate of patients, Intensive care unit admission rate of patients and the Length of hospital stay of the patients will be recorded

  14 days

• The following laboratory testing will be performed at least twice during the study period:

  14 days

Study Arms (4)

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

Dietary Supplement: Nigella Sativa capsule twice daily

group 3

ACTIVE COMPARATOR

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

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.

Dietary Supplement: Nigella Sativa capsule twice daily

Interventions

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 .

Also known as: single dose of vitamin D3 tablet (2000 IU) once daily

group 2; group 3; group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Respiratory System specialized hospital at Kobry Elobba Military Medical hospitals.

Cairo, 012345, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 31986264 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.

  PMID: 32179124 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.

  PMID: 32322478 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.

  PMID: 32269670 BACKGROUND

• 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.

  PMID: 36425571 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Nagwa A. Sabri, professor

  Department of Clinical Pharmacy

  STUDY CHAIR

Central Study Contacts

Amal A Elkholy

CONTACT

+201060355448; amalanas9@gmail.com

Shimaa A. Aly, Master

CONTACT

+201223844103; shimaa.aly90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled Parallel Open label Randomized Clinical Trial .

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 29, 2021
• Study Start: July 21, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

EG (1)