Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial
•N. sativa L. is a herbal medicine with antiviral and immunomodulatory activities that was suggested for COVID-19.•This open-label randomized controlled trial was designed to assess the potential efficacy of N. sativa L. oil for mild COVID-19.•N. sativa L. oil was associated with a higher chance of...
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| Published in | Complementary therapies in medicine Vol. 61; no. NA; p. 102769 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Scotland
Elsevier Ltd
01.09.2021
Elsevier Limited The Authors. Published by Elsevier Ltd Elsevier |
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| Online Access | Get full text |
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| Abstract | •N. sativa L. is a herbal medicine with antiviral and immunomodulatory activities that was suggested for COVID-19.•This open-label randomized controlled trial was designed to assess the potential efficacy of N. sativa L. oil for mild COVID-19.•N. sativa L. oil was associated with a higher chance of resolution of symptoms and faster recovery in adult patients with mild COVID-19.
Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19.
All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202).
A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001.
NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies. |
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| AbstractList | BackgroundEffective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19.MethodsAll adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202).ResultsA total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001.ConclusionsNSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies. Background: Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19. Methods: All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202). Results: A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001. Conclusions: NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies. Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19. All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202). A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001. NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies. Highlights: N. sativa L. is a herbal medicine with antiviral and immunomodulatory activities that was suggested for COVID-19. This open-label randomized controlled trial was designed to assess the potential efficacy of N. sativa L. oil for mild COVID-19. N. sativa L. oil was associated with a higher chance of resolution of symptoms and faster recovery in adult patients with mild COVID-19. Abstract: Background: Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19. Methods: All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202). Results: A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001. Conclusions: NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies. Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19.BACKGROUNDEffective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19.All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202).METHODSAll adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202).A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001.RESULTSA total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001.NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies.CONCLUSIONSNSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies. •N. sativa L. is a herbal medicine with antiviral and immunomodulatory activities that was suggested for COVID-19.•This open-label randomized controlled trial was designed to assess the potential efficacy of N. sativa L. oil for mild COVID-19.•N. sativa L. oil was associated with a higher chance of resolution of symptoms and faster recovery in adult patients with mild COVID-19. Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and immunomodulatory activities, and has been recommended for the treatment of COVID-19. This study aimed to evaluate the efficacy of NSO treatment in patients with COVID-19. All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. Symptoms were daily monitored via telecommunication. The primary outcome focused on the percentage of patients who recovered (symptom-free for 3 days) within 14-days. The trial was registered at clinicaltrials.gov (NCT04401202). A total of 173 patients were enrolled for RCT. The average age was 36(±11) years, and 53 % of patients were males. The control and NSO groups included 87 and 86 patients respectively. The percentage of recovered patients in NSO group (54[62 %]) was significantly higher than that in the control group (31[36 %]; p = 0.001). The mean duration to recovery was also shorter for patients receiving NSO (10.7 ± 3.2 days) compared with the control group (12.3 ± 2.8 days); p = 0.001. NSO supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies. |
| ArticleNumber | 102769 |
| Author | Alhamdan, Meshari M. Malibary, Husam M. Atwah, Ali F. Koshak, Emad A. Wali, Siraj O. Koshak, Abdulrahman E. Almalki, Reem A. Mobeireek, Abdullah F. Badawi, Mazen A. Madani, Tariq A. |
| Author_xml | – sequence: 1 givenname: Abdulrahman E. surname: Koshak fullname: Koshak, Abdulrahman E. email: aekoshak@kau.edu.sa organization: Department of Natural Products and Alternative Medicine, Faculty of Pharmacy, King Abdulaziz University 80260, Jeddah, 21589, Saudi Arabia – sequence: 2 givenname: Emad A. surname: Koshak fullname: Koshak, Emad A. organization: Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia – sequence: 3 givenname: Abdullah F. surname: Mobeireek fullname: Mobeireek, Abdullah F. organization: Department of Medicine, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia – sequence: 4 givenname: Mazen A. surname: Badawi fullname: Badawi, Mazen A. organization: Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia – sequence: 5 givenname: Siraj O. orcidid: 0000-0002-5825-5642 surname: Wali fullname: Wali, Siraj O. organization: Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia – sequence: 6 givenname: Husam M. orcidid: 0000-0003-1314-8031 surname: Malibary fullname: Malibary, Husam M. organization: Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia – sequence: 7 givenname: Ali F. surname: Atwah fullname: Atwah, Ali F. organization: Department of Pediatrics, Faculty of Medicine, King Abdulaziz University, Rabigh, Saudi Arabia – sequence: 8 givenname: Meshari M. surname: Alhamdan fullname: Alhamdan, Meshari M. organization: University Medical Services Centre, King Abdulaziz University, Jeddah, Saudi Arabia – sequence: 9 givenname: Reem A. surname: Almalki fullname: Almalki, Reem A. organization: Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia – sequence: 10 givenname: Tariq A. surname: Madani fullname: Madani, Tariq A. organization: Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34407441$$D View this record in MEDLINE/PubMed |
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| Keywords | IFNγ RCT IL Nigella sativa ITT KAUH NSO TNF COVID-19 Herbal medicine SARS-CoV-2 HIV ISARIC HCV WHO |
| Language | English |
| License | This is an open access article under the CC BY license. Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
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| Snippet | •N. sativa L. is a herbal medicine with antiviral and immunomodulatory activities that was suggested for COVID-19.•This open-label randomized controlled trial... Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral and... BackgroundEffective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with antiviral... Highlights: N. sativa L. is a herbal medicine with antiviral and immunomodulatory activities that was suggested for COVID-19. This open-label randomized... Background: Effective treatment for Coronavirus Disease-2019 (COVID-19) is under intensive research. Nigella sativa oil (NSO) is a herbal medicine with... |
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| SubjectTerms | Adult Antiviral Agents - therapeutic use Antiviral drugs Asthma Body mass index Clinical trials Coronaviruses COVID-19 COVID-19 Drug Treatment Female Good Manufacturing Practice Hepatitis Herbal medicine Hospitals Humans Immunomodulation Infections Male Middle Aged Nigella sativa Pandemics Patients Placebos Plant Extracts - therapeutic use Pneumonia SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Statistical analysis Supplements Treatment Outcome |
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| Title | Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial |
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