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

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. 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 5296

version: 15; Last updated: 2023-12-02 14:21:04+0000

Profile: PreprintCitation

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

identifier: FEvIR Object Identifier/5296, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.43

version: 2.0.0-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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*UsageContextType program: ProgramMCBK Example
*Citation Classification Type fevir-platform-use: FEvIR Platform UseProject Specific

jurisdiction: World

copyright:

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

author: Brian S. Alper:

summary

style: Computable Publishing

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

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

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

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

relatedIdentifier: https://clinicaltrials.gov/NCT04401202

Titles

-TypeLanguageText
*Primary titleEnglish

Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT)

Abstracts

-TypeLanguageTextCopyright
*Primary human useEnglish

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

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

Documents

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resourceReference: Identifier: FEvIR Object Identifier/6514

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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

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

resourceReference: Identifier: FEvIR Object Identifier/6512

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PublishedIns

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*DatabaseOSF Preprints

articleDate: 2020-08-03

language: English

pageCount: 2 pages

copyright:

CC-By Attribution 4.0 International

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classifier: DOI Based

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

webLocation

classifier: Abstract

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

classification

type: Knowledge Artifact Type

classifier: Preprint

classification

type: Study Type

classifier: Randomized Controlled Trial

contributorship

Summaries

-TypeSourceValue
*Author stringCopied from article

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