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 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Citation ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "5296"] ; # fhir:meta [ fhir:versionId [ fhir:v "15" ] ; fhir:lastUpdated [ fhir:v "2023-12-02T14:21:04.793Z"^^xsd:dateTime ] ; ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/preprint-citation"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/preprint-citation> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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 \r\n\r\nThis oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: \r\n\r\nNote that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.\r\n\r\nThis OID may also be used in CD.codeSystem.\">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.43</p><p><b>version</b>: 2.0.0-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>: </p><div><p>A preprint that has only an abstract and data is different than CT.gov results</p>\n</div><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><a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-usage-context-type.html#usage-context-type-program\">UsageContextType program</a>: Program</td><td><span title=\"Codes:\">MCBK Example</span></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"http://hl7.org/fhir/R5/codesystem-citation-classification-type.html#citation-classification-type-fevir-platform-use\">Citation Classification Type fevir-platform-use</a>: FEvIR Platform Use</td><td><span title=\"Codes:{http://hl7.org/fhir/citation-artifact-classifier project-specific}\">Project Specific</span></td></tr></table><p><b>jurisdiction</b>: <span title=\"Codes:{http://unstats.un.org/unsd/methods/m49/m49.htm 001}\">World</span></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</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>\n</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>\n</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>\n</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>\n</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>\n</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\nEffective 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>\n<p>Methods\nAdult 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>\n<p>Findings\nA 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>\n<p>Conclusions\nIn 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>\n</div></td><td><div><p>CC-By Attribution 4.0 International</p>\n</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: transformed-into</p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/citation-artifact-classifier fhir-resource}\">FHIR Resource</span>, <span title=\"Codes:{http://hl7.org/fhir/fhir-types Evidence}\">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>: Identifier: FEvIR Object Identifier/6513</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: transformed-into</p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/citation-artifact-classifier fhir-resource}\">FHIR Resource</span>, <span title=\"Codes:{http://hl7.org/fhir/fhir-types Evidence}\">Evidence</span></p><p><b>display</b>: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization - for Control 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/6514\">https://fevir.net/resources/Evidence/6514</a></td></tr></table><p><b>resourceReference</b>: Identifier: FEvIR Object Identifier/6514</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: transformed-into</p><p><b>classifier</b>: <span title=\"Codes:{http://hl7.org/fhir/citation-artifact-classifier fhir-resource}\">FHIR Resource</span>, <span title=\"Codes:{http://hl7.org/fhir/fhir-types Evidence}\">Evidence</span></p><p><b>display</b>: 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</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/6512\">https://fevir.net/resources/Evidence/6512</a></td></tr></table><p><b>resourceReference</b>: Identifier: FEvIR Object Identifier/6512</p></blockquote><blockquote><p><b>publicationForm</b></p><h3>PublishedIns</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/published-in-type D019991}\">Database</span></td><td>OSF Preprints</td></tr></table><p><b>articleDate</b>: 2020-08-03</p><p><b>language</b>: <span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></p><p><b>pageCount</b>: 2 pages</p><p><b>copyright</b>: </p><div><p>CC-By Attribution 4.0 International</p>\n</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>\n</div></td></tr></table></blockquote></blockquote></div>" ] ; # fhir:url [ fhir:v "https://fevir.net/resources/Citation/5296"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ; fhir:code [ fhir:v "ACSN" ] ; fhir:display [ fhir:v "Accession ID" ] ] ) ; fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ; fhir:system [ fhir:v "https://fevir.net"^^xsd:anyURI ] ; fhir:value [ fhir:v "5296" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.44.15.43" ] ] ) ; # fhir:version [ fhir:v "2.0.0-ballot"] ; # fhir:title [ fhir:v "PreprintCitation: Nigella Sativa for COVID-19 OSF Preprint"] ; # fhir:status [ fhir:v "active"] ; # fhir:date [ fhir:v "2021-10-25T15:17:23.312Z"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Clinical Decision Support" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/dss" ] ] ) ] ) ; # fhir:description [ fhir:v "A preprint that has only an abstract and data is different than CT.gov results"] ; # fhir:useContext ( [ fhir:code [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/usage-context-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "program" ] ; fhir:display [ fhir:v "Program" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "MCBK Example" ] ] ] [ fhir:code [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-classification-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "fevir-platform-use" ] ; fhir:display [ fhir:v "FEvIR Platform Use" ] ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-artifact-classifier"^^xsd:anyURI ] ; fhir:code [ fhir:v "project-specific" ] ; fhir:display [ fhir:v "Project Specific" ] ] ) ] ] ) ; # fhir:jurisdiction ( [ ( fhir:coding [ fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ; fhir:code [ fhir:v "001" ] ; fhir:display [ fhir:v "World" ] ] ) ] ) ; # fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # fhir:author ( [ fhir:name [ fhir:v "Brian S. Alper" ] ] ) ; # fhir:summary ( [ fhir:style [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-summary-style"^^xsd:anyURI ] ; fhir:code [ fhir:v "comppub" ] ; fhir:display [ fhir:v "Computable Publishing" ] ] ) ] ; fhir:text [ fhir:v "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." ] ] [ fhir:style [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-summary-style"^^xsd:anyURI ] ; fhir:code [ fhir:v "apa7" ] ; fhir:display [ fhir:v "American Psychological Association 7th edition" ] ] ) ; fhir:text [ fhir:v "APA" ] ] ; fhir:text [ fhir:v "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" ] ] [ fhir:style [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ] ; fhir:code [ fhir:v "defined-in-text" ] ; fhir:display [ fhir:v "Defined in text" ] ] ) ; fhir:text [ fhir:v "MLA" ] ] ; fhir:text [ fhir:v "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." ] ] [ fhir:style [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-summary-style"^^xsd:anyURI ] ; fhir:code [ fhir:v "chicago-a-17" ] ; fhir:display [ fhir:v "Chicago Style Version 17 Author Date" ] ] ) ; fhir:text [ fhir:v "Chicago" ] ] ; fhir:text [ fhir:v "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." ] ] ) ; # fhir:citedArtifact [ ( fhir:identifier [ fhir:system [ fhir:v "https://doi.org"^^xsd:anyURI ] ; fhir:value [ fhir:v "10.31219/osf.io/urb6f" ] ] ) ; ( fhir:relatedIdentifier [ fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ; fhir:value [ fhir:v "NCT04401202" ] ; fhir:assigner [ fhir:display [ fhir:v "NLM" ] ] ] ) ; ( fhir:title [ ( fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "primary" ] ; fhir:display [ fhir:v "Primary title" ] ] ) ] ) ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "English" ] ] ) ] ; fhir:text [ fhir:v "Nigella Sativa Supplementation Accelerates Recovery from Mild COVID-19: First Randomized Controlled Clinical Trial (RCT)" ] ] ) ; ( fhir:abstract [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/cited-artifact-abstract-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "primary-human-use" ] ; fhir:display [ fhir:v "Primary human use" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "English" ] ] ) ] ; fhir:text [ fhir:v "Background\nEffective 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.\n\nMethods\nAdult 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.\n\nFindings\nA 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.\n\nConclusions\nIn 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." ] ; fhir:copyright [ fhir:v "CC-By Attribution 4.0 International" ] ] ) ; ( fhir:relatesTo [ fhir:type [ fhir:v "transformed-into" ] ; ( fhir:classifier [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/citation-artifact-classifier"^^xsd:anyURI ] ; fhir:code [ fhir:v "fhir-resource" ] ; fhir:display [ fhir:v "FHIR Resource" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/fhir-types"^^xsd:anyURI ] ; fhir:code [ fhir:v "Evidence" ] ; fhir:display [ fhir:v "Evidence" ] ] ) ; fhir:text [ fhir:v "Evidence" ] ] ) ; fhir:display [ fhir:v "Percentage of Participants With Clinical Recovery Within 14 Days After Randomization - for Nigella Sativa Oil in Nigella Sativa for COVID-19 OSF Preprint" ] ; fhir:document [ fhir:url [ fhir:v "https://fevir.net/resources/Evidence/6513"^^xsd:anyURI ] ] ; 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fhir:value [ fhir:v "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" ] ] ) ] ] . #
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-11-22
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