Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot International flag

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example Citation: PreprintCitation: Nigella Sativa for COVID-19 OSF Preprint

Active as of 2021-10-25

Generated Narrative: Citation

Resource Citation "5296" Version "15" Updated "2023-12-02 14:21:04+0000"

Profile: PreprintCitation

StructureDefinition Work Group: cds

url: https://fevir.net/resources/Citation/5296

identifier: FEvIR Object Identifier: 5296

version: 1.0.0-ballot

title: PreprintCitation: Nigella Sativa for COVID-19 OSF Preprint

status: active

date: 2021-10-25 15:17:23+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

description: A preprint that has only an abstract and data is different than CT.gov results

UseContexts

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*FEvIR Platform Use (Details: http://hl7.org/fhir/citation-classification-type code fevir-platform-use = 'FEvIR Platform Use', stated as 'FEvIR Platform Use')Project Specific (Citation Artifact Classifier#project-specific)

jurisdiction: World (m49.htm#001)

copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/

author: Brian S. Alper:

summary

style: Computable Publishing (Citation Summary Style#comppub)

text: Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT) [Preprint]. Contributors: Abdulrahman E. Koshak, Emad A. Koshak, Abdullah F. Mobeireek, Mazen A. Badawi, Siraj O. Wali, Husam M. Malibary, Ali F. Atwah, Meshari M. Alhamdan, Reem A. Almalki, Tariq A. Madani. In: OSF Preprints, DOI 10.31219/osf.io/urb6f. Published August 03, 2020. Available at: https://doi.org/10.31219/osf.io/urb6f.

summary

style: APA (Citation Summary Style#apa7 "American Psychological Association 7th edition")

text: Koshak, A. E., Koshak, E. A., Mobeireek, A. F., Badawi, M. A., Wali, S. O., Malibary, H. M., … Madani, T. A. (2020, August 3). Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT). https://doi.org/10.31219/osf.io/urb6f

summary

style: MLA (Evidence Based Medicine on FHIR Implementation Guide Code System#defined-in-text "Defined in text")

text: Koshak, Abdulrahman E., et al. “Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT).” OSF Preprints, 3 Aug. 2020. Web.

summary

style: Chicago (Citation Summary Style#chicago-a-17 "Chicago Style Version 17 Author Date")

text: Koshak, Abdulrahman E., Emad A. Koshak, Abdullah F. Mobeireek, Mazen A. Badawi, Siraj O. Wali, Husam M. Malibary, Ali F. Atwah, et al. 2020. “Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT).” OSF Preprints. August 3. doi:10.31219/osf.io/urb6f.

citedArtifact

identifier: id: 10.31219/osf.io/urb6f

relatedIdentifier: id: NCT04401202

Titles

-TypeLanguageText
*Primary title (Title Type#primary)English (Tags for the Identification of Languages#en)Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT)

Abstracts

-TypeLanguageTextCopyright
*Primary human use (Cited Artifact Abstract Type#primary-human-use)English (Tags for the Identification of Languages#en)Background Effective treatment for patients with the novel Coronavirus Disease (COVID-19) is desperately needed and is under rigorous research. Nigella sativa oil (NSO), a herbal medicine, that has a documented wide antiviral and immunomodulatory activities offering a therapeutic potential for COVID-19. Methods Adult symptomatic patients with mild COVID-19 were recruited between May and August 2020 from King Abdulaziz University Hospital in Jeddah, Saudi Arabia. They were randomly assigned to receive supplementation with oral capsules of NSO (MARNYS® Cuminmar 500 mg twice daily for 10 days) plus standard of care or standard of care medications alone. The primary endpoint was the proportion of patients recovered (free of symptoms for 3 days) within 14 days after randomization. This trial was registered with clinicaltrials.gov, NCT04401202. Findings A total of 94 patients were enrolled. Their mean age was 35 (SD=11) years old and 57% of them were male. There were 47 patients in the treatment group (NSO) and 47 patients in the control group. The proportion of patients recovered in the treatment group was significantly higher than the control group, 37 (79%) versus 21 (45%) (p=0.001). Additionally, there was a significant difference in the average recovery time among both groups, 9 (SD=3) versus 11 (SD=3) days (p=0.003). Furthermore, 2 patients from the control group required hospitalization within the study period versus none in the treatment group. Adverse events were reported in 3 patients of NSO recipients as gastrointestinal symptoms. Conclusions In this RCT of adult patients with mild COVID-19, NSO was associated with a significant increase in the likelihood of recovery and a decrease in the likelihood of hospitalization. To our knowledge, this is the first RCT that shows potential therapeutic benefits of NSO in patients with COVID-19 which requires further confirmation with larger double-blinded RCTs.CC-By Attribution 4.0 International

relatesTo

type: transformed-into

classifier: FHIR Resource (Citation Artifact Classifier#fhir-resource), Evidence (All FHIR Types#Evidence)

display: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization - for Nigella Sativa Oil in Nigella Sativa for COVID-19 OSF Preprint

Documents

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resourceReference: FEvIR Object Identifier: 6513

relatesTo

type: transformed-into

classifier: FHIR Resource (Citation Artifact Classifier#fhir-resource), Evidence (All FHIR Types#Evidence)

display: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization - for Control in Nigella Sativa for COVID-19 OSF Preprint

Documents

-Url
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resourceReference: FEvIR Object Identifier: 6514

relatesTo

type: transformed-into

classifier: FHIR Resource (Citation Artifact Classifier#fhir-resource), Evidence (All FHIR Types#Evidence)

display: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization Statistical Analysis for Nigella Sativa Oil vs Control in Nigella Sativa for COVID-19 OSF Preprint

Documents

-Url
*https://fevir.net/resources/Evidence/6512

resourceReference: FEvIR Object Identifier: 6512

publicationForm

PublishedIns

-TypeTitle
*Database (Published In Type#D019991)OSF Preprints

articleDate: 2020-08-03

language: English (Tags for the Identification of Languages#en)

pageCount: 2 pages

copyright: CC-By Attribution 4.0 International

webLocation

classifier: DOI Based (Artifact Url Classifier#doi-based)

url: https://doi.org/10.31219/osf.io/urb6f

webLocation

classifier: Abstract (Artifact Url Classifier#abstract)

url: https://osf.io/urb6f/

classification

type: Knowledge Artifact Type (Cited Artifact Classification Type#knowledge-artifact-type)

classifier: Preprint (Citation Artifact Classifier#D000076942)

classification

type: Study Type (Evidence Based Medicine on FHIR Implementation Guide Code System#study-design "Study Design")

classifier: Randomized Controlled Trial (Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide#SEVCO:01003 "randomized assignment")

contributorship

Summaries

-TypeSourceValue
*Author string (Contributor Summary Type#author-string)Copied from article (Contributor Summary Source#article-copy)Abdulrahman E. Koshak, Emad A. Koshak, Abdullah F. Mobeireek, Mazen A. Badawi, Siraj O. Wali, Husam M. Malibary, Ali F. Atwah, Meshari M. Alhamdan, Reem A. Almalki, Tariq A. Madani