Honey and Nigella Sativa in the Prophylaxis of COVID-19; A Randomized Controlled Trial

Honey and Nigella Sativa in the Prophylaxis of COVID-19; A Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Honey and Nigella Sativa in the Prophylaxis of COVID-19; A Randomized Controlled Trial Sohaib Ashraf, Shoaib Ashraf, Rutaba Akmal, Moneeb Ashraf, Larab Kalsoom, and 46 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-757643/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Objectives Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS. Trial design The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial. Participants All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study ● High-risk exposure (10min without face protection) ● Moderate exposure (10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan). Intervention and comparator In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan. Main outcomes Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14 th day of randomization. Randomisation Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure. Blinding (masking) Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking. Numbers to be randomised (sample size) 1000 participants will be enrolled in the study with 1:1 allocation. Trial Status The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022. Trial registration Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 . Internal Medicine Clinical Pharmacology Honey Nigella Sativa Prophetic Medicine Pakistan COVID-19 Randomised controlled trial Protocol Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. declarations Ethics approval and consent to participate The trial was approved by institutional ethical review board of Shaikh Zayed Post-Graduate Medical Complex (IRB ID # SZMC/IRB/Internal/273/2021 ) on February 15, 2021. Authors certify that the study has received ethical approval from the appropriate ethical committee as stated above. Before enrolment, all partakers will be fully informed of the study and asked to sign the consent form to be eligible for randomization and participation. Consent for publication Not applicable Availability of data and materials All required data will be posted along with the trial results and final trail dataset requests can be made to Dr. Sohaib Ashraf which could be available from the author on reasonable appeal subject to data protection regulations. (Twitter: SohaibAshrafMD, email address: [email protected] , Mobile Number: +92 3334474523) Competing interests The authors declare that they have no competing interests. Funding Funding by Smile Welfare Organization (SWO) - a non-profitable organization. The funder played no role in the design of the study, in the collection, analysis, and interpretation of data, and in writing the manuscript. Authors' contributions SA, ShA, MA, AM, SA, MAI, LK, UNS, NM, IF, RK, and MG contributed equally to this paper and share joint first authorship. SA, ShA, MA, AM, and AA are joint corresponding authors. KAUNS, NM, IF and RA contributed equally and share joint second authorship. SA, ShA, MA, AM, SA, MAI, LK, RK and MG added to the conception, designing and manuscript drafting. SA, ShA and MoA proposed the hypothesis and study design. MA, MuA, SiA, MKA, NM, MG, ZH, MKA, SR, ZH, ZS, contributed biochemical, dosimetry, pharmacological as well as pharmaceutical inputs. SA, MoA, SR, AZ, RK and SR drafted the first version of the manuscript. Doctors Lounge Consortium IF, RA, MSS, SR, AH, AM, ZS, ZA, AK, KH, GAm, MiK, SA, MH, QuAI, AmA, ABA, MU,, ABH, SSHS, ZS, AnA, MK, TM and MU contributed significantly to designing the final methodology. MKA, SoA, and AH provided statistical inputs. AAM, UsI, MSu, SZ, SS, SSA, MIA, AmM, TM, AH, YMA, QAS, AA, MoA and MI have contributed to intellectual inputs in the study protocol and methodology along with final manuscript write up. All authors are responsible for their contributions, providing critical edits and final authorization of the article. The corresponding authors attest trial validity and authenticity. Acknowledgements The authors would like to acknowledge Prof. Dr. Zaheer Ahmad, PhD (Department of botany, Government College University, Lahore, Pakistan). We pay gratitude to late Prof. Dr. Zia Ullah (Internal Medicine, Shaikh Zayed Post-Graduate Medical Complex) who died while serving humanity and combating COVID-19. We are particularly grateful for the help of our local collaborators including DOCTORS LOUNGE Consortium. DOCTORS LOUNGE Consortium Arz Muhammad 1 , Kanwal Hayat 1 , Ghazala Amjad 1 , Misbah Kousar 1 , Umair Hafeez 1 , Tayyab Mughal 1 , Tayyaba Muzafar 1 , Sibgha Zulfiqar 1 , Saadia Shahzad Alam 1 , Muhammad Imran Anwar 1 , Amber Malik 1 , Talha Mahmud 1 , Ali Arshad 2 , Khawar Nawaz 3 , Muhammad Ismail Khalid Yousaf 4 Affiliations: 1, Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan. 2, Kingedward Medical University, Lahore, Pakistan. 3, Sunny Downstate/Kings Country Medical Center, New York, USA. 4. University of Louisville, Kentucky, USA. Supplementary Files ProtocolHNSCOVIDPKIIProphylaxis.pdf Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 04 Aug, 2021 Reviewers invited by journal 04 Aug, 2021 Editor invited by journal 02 Aug, 2021 First submitted to journal 27 Jul, 2021 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-757643","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":43854344,"identity":"8f80dd65-ff52-42e2-bb26-fdcc97a382a5","order_by":0,"name":"Sohaib 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14:24:06","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":398933,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-757643/v1/5dbcca19-e940-4090-83bb-425a90828928.pdf"},{"id":12250547,"identity":"70c57639-1d43-4b4f-ab09-3e5b7e40849f","added_by":"auto","created_at":"2021-08-09 15:23:37","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":396086,"visible":true,"origin":"","legend":"","description":"","filename":"ProtocolHNSCOVIDPKIIProphylaxis.pdf","url":"https://assets-eu.researchsquare.com/files/rs-757643/v1/0f056c93f64157aa4b3a10a8.pdf"}],"financialInterests":"","formattedTitle":"\u003cp\u003eHoney and \u003cem\u003eNigella \u003c/em\u003eSativa in the Prophylaxis of COVID-19; A Randomized Controlled Trial\u003c/p\u003e","fulltext":[{"header":"Full protocol","content":"\u003cp\u003eThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.\u003c/p\u003e"},{"header":"declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was approved by institutional ethical review board of Shaikh Zayed Post-Graduate Medical Complex (IRB ID # \u003cstrong\u003eSZMC/IRB/Internal/273/2021\u003c/strong\u003e) on February 15, 2021.\u0026nbsp;Authors certify that the study has received ethical approval from the appropriate ethical committee as stated above. Before enrolment, all partakers will be fully informed of the study and asked to sign the consent form to be\u0026nbsp;eligible for randomization and participation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll required data will be posted along with the trial results and final trail dataset requests can be made to Dr. Sohaib Ashraf which could be available from the author on reasonable appeal subject to\u0026nbsp;data protection regulations. (Twitter: SohaibAshrafMD, email address:\u0026nbsp;\u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003cu\u003e,\u003c/u\u003e Mobile Number: +92 3334474523)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFunding by Smile Welfare Organization (SWO) - a non-profitable organization. The funder played no role in the design of the study, in the collection, analysis, and interpretation of data, and in writing the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSA, ShA, MA, AM, SA, MAI, LK, UNS, NM, IF, RK, and MG contributed equally to this paper and share joint first authorship. SA, ShA, MA, AM, and AA are joint corresponding authors. KAUNS, NM, IF and RA contributed equally and share joint second authorship. SA, ShA, MA, AM, SA, MAI, LK, RK and MG added to the conception, designing and manuscript drafting. SA, ShA and MoA proposed the hypothesis and study design. MA, MuA, SiA, MKA, NM, MG, ZH, MKA, SR, ZH, ZS, contributed biochemical, dosimetry, pharmacological as well as pharmaceutical inputs. SA, MoA, SR, AZ, RK and SR drafted the first version of the manuscript. Doctors Lounge Consortium IF, RA, MSS, SR, AH, AM, ZS, ZA, AK, KH, GAm, MiK, SA, MH, QuAI, AmA, ABA, MU,, ABH, SSHS, ZS, AnA, MK, TM and MU contributed significantly to designing the final methodology. MKA, SoA, and AH provided statistical inputs. AAM, UsI, MSu, SZ, SS, SSA, MIA, AmM, TM, AH, YMA, QAS, AA, MoA and MI have contributed to intellectual inputs in the study protocol and methodology along with final manuscript write up. All authors are responsible for their contributions, providing critical edits and final authorization of the article. The corresponding authors attest trial validity and authenticity.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to acknowledge Prof. Dr. Zaheer Ahmad, PhD (Department of botany, Government College University, Lahore, Pakistan). We pay gratitude to late Prof. Dr. Zia Ullah (Internal Medicine, Shaikh Zayed Post-Graduate Medical Complex) who died while serving humanity and combating COVID-19. We are particularly grateful for the help of our local collaborators including DOCTORS LOUNGE Consortium.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOCTORS LOUNGE Consortium\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eArz Muhammad\u003csup\u003e1\u003c/sup\u003e, Kanwal Hayat\u003csup\u003e1\u003c/sup\u003e, Ghazala Amjad\u003csup\u003e1\u003c/sup\u003e, Misbah Kousar\u003csup\u003e1\u003c/sup\u003e, Umair Hafeez\u003csup\u003e1\u003c/sup\u003e, Tayyab Mughal\u003csup\u003e1\u003c/sup\u003e, Tayyaba Muzafar\u003csup\u003e1\u003c/sup\u003e, Sibgha Zulfiqar\u003csup\u003e1\u003c/sup\u003e, Saadia Shahzad Alam\u003csup\u003e1\u003c/sup\u003e, Muhammad Imran Anwar\u003csup\u003e1\u003c/sup\u003e, Amber Malik\u003csup\u003e1\u003c/sup\u003e, Talha Mahmud\u003csup\u003e1\u003c/sup\u003e, Ali Arshad\u003csup\u003e2\u003c/sup\u003e, Khawar Nawaz\u003csup\u003e3\u003c/sup\u003e, Muhammad Ismail Khalid Yousaf\u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAffiliations:\u0026nbsp;\u003c/strong\u003e1, Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan. 2, Kingedward Medical University, Lahore, Pakistan.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e3, Sunny Downstate/Kings Country Medical Center, New York, USA.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e4. University of Louisville, Kentucky, USA.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Honey, Nigella Sativa, Prophetic Medicine, Pakistan, COVID-19, Randomised controlled trial, Protocol","lastPublishedDoi":"10.21203/rs.3.rs-757643/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-757643/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjectives\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eConsidering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial design\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eThe study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eAll asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study\u003c/p\u003e\u003cp\u003e●\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;High-risk exposure (\u0026lt;6 feet distance for \u0026gt;10min without face protection) \u003c/p\u003e\u003cp\u003e●\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;Moderate exposure (\u0026lt;6 feet distance for \u0026gt;10min with face protection)\u003c/p\u003e\u003cp\u003eSubjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study.\u003c/p\u003e\u003cp\u003eRecruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan). \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eIntervention and comparator\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eIn this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMain outcomes\u003c/strong\u003e\u003c/p\u003e\u003cp\u003ePrimary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14\u003csup\u003eth\u003c/sup\u003e day of randomization. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eRandomisation\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eParticipants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure. \u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eBlinding (masking)\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eQuadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eNumbers to be randomised (sample size)\u003c/strong\u003e\u003c/p\u003e\u003cp\u003e1000 participants will be enrolled in the study with 1:1 allocation.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial Status\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eThe final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eClinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT04767087\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cstrong\u003eNCT04767087\u003c/strong\u003e\u003c/a\u003e.\u003c/p\u003e","manuscriptTitle":"Honey and Nigella Sativa in the Prophylaxis of COVID-19; A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2021-08-09 15:23:35","doi":"10.21203/rs.3.rs-757643/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2021-08-04T08:16:50+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2021-08-04T06:29:39+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Trials","date":"2021-08-02T10:35:50+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2021-07-27T19:22:51+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3bab5d7c-ed94-4028-aef4-a1e824ef7ad0","owner":[],"postedDate":"August 9th, 2021","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":6277519,"name":"Internal Medicine"},{"id":6277520,"name":"Clinical Pharmacology"}],"tags":[],"updatedAt":"2021-08-09T15:23:35+00:00","versionOfRecord":[],"versionCreatedAt":"2021-08-09 15:23:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-757643","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-757643","identity":"rs-757643","version":["v1"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}