Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
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
| Active as of 2021-10-25 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Citation</b><a name="5296"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Citation "5296" Version "15" Updated "2023-12-02 14:21:04+0000" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-preprint-citation.html">PreprintCitation</a></p></div><p><b>StructureDefinition Work Group</b>: cds</p><p><b>url</b>: <code>https://fevir.net/resources/Citation/5296</code></p><p><b>identifier</b>: FEvIR Object Identifier: 5296</p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: PreprintCitation: Nigella Sativa for COVID-19 OSF Preprint</p><p><b>status</b>: active</p><p><b>date</b>: 2021-10-25 15:17:23+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: A preprint that has only an abstract and data is different than CT.gov results</p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Program (Details: http://terminology.hl7.org/CodeSystem/usage-context-type code program = 'Program', stated as 'Program')</td><td>MCBK Example <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr><tr><td style="display: none">*</td><td>FEvIR Platform Use (Details: http://hl7.org/fhir/citation-classification-type code fevir-platform-use = 'FEvIR Platform Use', stated as 'FEvIR Platform Use')</td><td>Project Specific <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#project-specific)</span></td></tr></table><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>author</b>: Brian S. Alper: </p><blockquote><p><b>summary</b></p><p><b>style</b>: Computable Publishing <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-summary-style.html">Citation Summary Style</a>#comppub)</span></p><p><b>text</b>: 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.</p></blockquote><blockquote><p><b>summary</b></p><p><b>style</b>: APA <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-summary-style.html">Citation Summary Style</a>#apa7 "American Psychological Association 7th edition")</span></p><p><b>text</b>: 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</p></blockquote><blockquote><p><b>summary</b></p><p><b>style</b>: MLA <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#defined-in-text "Defined in text")</span></p><p><b>text</b>: 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.</p></blockquote><blockquote><p><b>summary</b></p><p><b>style</b>: Chicago <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-summary-style.html">Citation Summary Style</a>#chicago-a-17 "Chicago Style Version 17 Author Date")</span></p><p><b>text</b>: 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.</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: id: 10.31219/osf.io/urb6f</p><p><b>relatedIdentifier</b>: id: NCT04401202</p><h3>Titles</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>Primary title <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-title-type.html">Title Type</a>#primary)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td><td>Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT)</td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td>Primary human use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-abstract-type.html">Cited Artifact Abstract Type</a>#primary-human-use)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td><td>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.</td><td>CC-By Attribution 4.0 International</td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: transformed-into</p><p><b>classifier</b>: FHIR Resource <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#fhir-resource)</span>, Evidence <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-fhir-types.html">All FHIR Types</a>#Evidence)</span></p><p><b>display</b>: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization - for Nigella Sativa Oil in Nigella Sativa for COVID-19 OSF Preprint</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://fevir.net/resources/Evidence/6513">https://fevir.net/resources/Evidence/6513</a></td></tr></table><p><b>resourceReference</b>: <span>FEvIR Object Identifier: 6513</span></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: transformed-into</p><p><b>classifier</b>: FHIR Resource <span style="background: LightGoldenRodYellow; 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margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-published-in-type.html">Published In Type</a>#D019991)</span></td><td>OSF Preprints</td></tr></table><p><b>articleDate</b>: 2020-08-03</p><p><b>language</b>: English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></p><p><b>pageCount</b>: 2 pages</p><p><b>copyright</b>: CC-By Attribution 4.0 International</p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: DOI Based <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#doi-based)</span></p><p><b>url</b>: <a href="https://doi.org/10.31219/osf.io/urb6f">https://doi.org/10.31219/osf.io/urb6f</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: Abstract <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-artifact-url-classifier.html">Artifact Url Classifier</a>#abstract)</span></p><p><b>url</b>: <a href="https://osf.io/urb6f/">https://osf.io/urb6f/</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Knowledge Artifact Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#knowledge-artifact-type)</span></p><p><b>classifier</b>: Preprint <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D000076942)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Study Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-179423.html">Evidence Based Medicine on FHIR Implementation Guide Code System</a>#study-design "Study Design")</span></p><p><b>classifier</b>: Randomized Controlled Trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:01003 "randomized assignment")</span></p></blockquote><blockquote><p><b>contributorship</b></p><h3>Summaries</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Source</b></td><td><b>Value</b></td></tr><tr><td style="display: none">*</td><td>Author string <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-type.html">Contributor Summary Type</a>#author-string)</span></td><td>Copied from article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-contributor-summary-source.html">Contributor Summary Source</a>#article-copy)</span></td><td>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</td></tr></table></blockquote></blockquote></div>
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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."/>
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IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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