Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
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
| Active as of 2021-10-25 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 5296</b></p><a name="5296"> </a><a name="hc5296"> </a><a name="5296-en-US"> </a><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">version: 15; Last 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>url</b>: <a href="Citation-5296.html">Citation PreprintCitation: Nigella Sativa for COVID-19 OSF Preprint</a></p><p><b>identifier</b>: FEvIR Object Identifier/5296, <a href="http://terminology.hl7.org/6.1.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
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</div><p><b>author</b>: Brian S. Alper: </p><blockquote><p><b>summary</b></p><p><b>style</b>: <span title="Codes:{http://hl7.org/fhir/citation-summary-style comppub}">Computable Publishing</span></p><p><b>text</b>: </p><div><p>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>
</div></blockquote><blockquote><p><b>summary</b></p><p><b>style</b>: <span title="Codes:{http://hl7.org/fhir/citation-summary-style apa7}">APA</span></p><p><b>text</b>: </p><div><p>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>
</div></blockquote><blockquote><p><b>summary</b></p><p><b>style</b>: <span title="Codes:{https://fevir.net/resources/CodeSystem/179423 defined-in-text}">MLA</span></p><p><b>text</b>: </p><div><p>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>
</div></blockquote><blockquote><p><b>summary</b></p><p><b>style</b>: <span title="Codes:{http://hl7.org/fhir/citation-summary-style chicago-a-17}">Chicago</span></p><p><b>text</b>: </p><div><p>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>
</div></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://doi.org</code>/10.31219/osf.io/urb6f</p><p><b>relatedIdentifier</b>: <code>https://clinicaltrials.gov</code>/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><span title="Codes:{http://hl7.org/fhir/title-type primary}">Primary title</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td><td><div><p>Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT)</p>
</div></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><span title="Codes:{http://hl7.org/fhir/cited-artifact-abstract-type primary-human-use}">Primary human use</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td><td><div><p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
</div></td><td><div><p>CC-By Attribution 4.0 International</p>
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</div></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/artifact-url-classifier doi-based}">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>: <span title="Codes:{http://hl7.org/fhir/artifact-url-classifier abstract}">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>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type knowledge-artifact-type}">Knowledge Artifact Type</span></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D000076942}">Preprint</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{https://fevir.net/resources/CodeSystem/179423 study-design}">Study Type</span></p><p><b>classifier</b>: <span title="Codes:{https://fevir.net/resources/CodeSystem/181513 SEVCO:01003}">Randomized Controlled Trial</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><span title="Codes:{http://hl7.org/fhir/contributor-summary-type author-string}">Author string</span></td><td><span title="Codes:{http://hl7.org/fhir/contributor-summary-source article-copy}">Copied from article</span></td><td><div><p>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</p>
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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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<text value="FEvIR Object Identifier"/>
</type>
<system value="https://fevir.net"/>
<value value="6512"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</resourceReference>
</relatesTo>
<publicationForm>
<publishedIn>
<type>
<coding>
<system value="http://hl7.org/fhir/published-in-type"/>
<code value="D019991"/>
<display value="Database"/>
</coding>
</type>
<title value="OSF Preprints"/>
</publishedIn>
<articleDate value="2020-08-03"/>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="English"/>
</coding>
</language>
<pageCount value="2 pages"/>
<copyright value="CC-By Attribution 4.0 International"/>
</publicationForm>
<webLocation>
<classifier>
<coding>
<system value="http://hl7.org/fhir/artifact-url-classifier"/>
<code value="doi-based"/>
<display value="DOI Based"/>
</coding>
</classifier>
<url value="https://doi.org/10.31219/osf.io/urb6f"/>
</webLocation>
<webLocation>
<classifier>
<coding>
<system value="http://hl7.org/fhir/artifact-url-classifier"/>
<code value="abstract"/>
<display value="Abstract"/>
</coding>
</classifier>
<url value="https://osf.io/urb6f/"/>
</webLocation>
<classification>
<type>
<coding>
<system
value="http://hl7.org/fhir/cited-artifact-classification-type"/>
<code value="knowledge-artifact-type"/>
<display value="Knowledge Artifact Type"/>
</coding>
</type>
<classifier>
<coding>
<system value="http://hl7.org/fhir/citation-artifact-classifier"/>
<code value="D000076942"/>
<display value="Preprint"/>
</coding>
</classifier>
</classification>
<classification>
<type>
<coding>
<system value="https://fevir.net/resources/CodeSystem/179423"/>
<code value="study-design"/>
<display value="Study Design"/>
</coding>
<text value="Study Type"/>
</type>
<classifier>
<coding>
<system value="https://fevir.net/resources/CodeSystem/181513"/>
<code value="SEVCO:01003"/>
<display value="randomized assignment"/>
</coding>
<text value="Randomized Controlled Trial"/>
</classifier>
</classification>
<contributorship>
<summary>
<type>
<coding>
<system value="http://hl7.org/fhir/contributor-summary-type"/>
<code value="author-string"/>
<display value="Author string"/>
</coding>
</type>
<source>
<coding>
<system value="http://hl7.org/fhir/contributor-summary-source"/>
<code value="article-copy"/>
<display value="Copied from article"/>
</coding>
</source>
<value
value="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"/>
</summary>
</contributorship>
</citedArtifact>
</Citation>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
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