Efficacy and safety of Link Natural Sudarshana, an Ayurvedic herbal preparation in COVID-19 patients: A phase II multicenter double-blind randomized placebo-controlled trial

DOI record: { "DOI": "10.1016/j.jep.2023.117535", "ISSN": [ "0378-8741" ], "URL": "http://dx.doi.org/10.1016/j.jep.2023.117535", "alternative-id": [ "S0378874123014058" ], "article-number": "117535", "assertion": [ { "label": "This article is maintained by", "name": "publisher", "value": "Elsevier" }, { "label": "Article Title", "name": "articletitle", "value": "Efficacy and safety of Link Natural Sudarshana, an Ayurvedic herbal preparation in COVID-19 patients: A phase II multicenter double-blind randomized placebo-controlled trial" }, { "label": "Journal Title", "name": "journaltitle", "value": "Journal of Ethnopharmacology" }, { "label": "CrossRef DOI link to publisher maintained version", "name": "articlelink", "value": "https://doi.org/10.1016/j.jep.2023.117535" }, { "label": "Content Type", "name": "content_type", "value": "article" }, { "label": "Copyright", "name": "copyright", "value": "© 2023 Published by Elsevier B.V." } ], "author": [ { "ORCID": "http://orcid.org/0000-0003-2723-1813", "affiliation": [], "authenticated-orcid": false, "family": "Wijewickrama", "given": "Ananda", "sequence": "first" }, { "affiliation": [], "family": "Idampitiya", "given": "Damayanthi", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0006-4279-6205", "affiliation": [], "authenticated-orcid": false, "family": "Karunarathne", "given": "Malika", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0001-3557-2856", "affiliation": [], "authenticated-orcid": false, "family": "Pahalagamage", "given": "Sithumini", "sequence": "additional" }, { "affiliation": [], "family": "Sellahewa", "given": "Kolitha", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0001-6795-7913", "affiliation": [], "authenticated-orcid": false, "family": "Govindapala", "given": "Dumitha", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0002-2067-7943", "affiliation": [], "authenticated-orcid": false, "family": "Kalambarachchi", "given": "Himal", "sequence": "additional" }, { "affiliation": [], "family": "Sooriyarachchi", "given": "Roshini", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-3093-9102", "affiliation": [], "authenticated-orcid": false, "family": "Chandrarathne", "given": "Nadeeka", "sequence": "additional" }, { "affiliation": [], "family": "Goonaratna", "given": "Colvin", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-7450-5672", "affiliation": [], "authenticated-orcid": false, "family": "Perera", "given": "Jennifer", "sequence": "additional" } ], "container-title": "Journal of Ethnopharmacology", "container-title-short": "Journal of Ethnopharmacology", "content-domain": { "crossmark-restriction": true, "domain": [ "elsevier.com", "sciencedirect.com" ] }, "created": { "date-parts": [ [ 2023, 12, 7 ] ], "date-time": "2023-12-07T17:14:20Z", "timestamp": 1701969260000 }, "deposited": { "date-parts": [ [ 2023, 12, 7 ] ], "date-time": "2023-12-07T17:14:36Z", "timestamp": 1701969276000 }, "indexed": { "date-parts": [ [ 2023, 12, 8 ] ], "date-time": "2023-12-08T00:52:16Z", "timestamp": 1701996736947 }, "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2023, 12 ] ] }, "language": "en", "license": [ { "URL": "https://www.elsevier.com/tdm/userlicense/1.0/", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 12, 1 ] ], "date-time": "2023-12-01T00:00:00Z", "timestamp": 1701388800000 } }, { "URL": "https://doi.org/10.15223/policy-017", "content-version": "stm-asf", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 12, 1 ] ], "date-time": "2023-12-01T00:00:00Z", "timestamp": 1701388800000 } }, { "URL": "https://doi.org/10.15223/policy-037", "content-version": "stm-asf", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 12, 1 ] ], "date-time": "2023-12-01T00:00:00Z", "timestamp": 1701388800000 } }, { "URL": "https://doi.org/10.15223/policy-012", "content-version": "stm-asf", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 12, 1 ] ], "date-time": "2023-12-01T00:00:00Z", "timestamp": 1701388800000 } }, { "URL": "https://doi.org/10.15223/policy-029", "content-version": "stm-asf", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 12, 1 ] ], "date-time": "2023-12-01T00:00:00Z", "timestamp": 1701388800000 } }, { "URL": "https://doi.org/10.15223/policy-004", "content-version": "stm-asf", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 12, 1 ] ], "date-time": "2023-12-01T00:00:00Z", "timestamp": 1701388800000 } } ], "link": [ { "URL": "https://api.elsevier.com/content/article/PII:S0378874123014058?httpAccept=text/xml", "content-type": "text/xml", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://api.elsevier.com/content/article/PII:S0378874123014058?httpAccept=text/plain", "content-type": "text/plain", "content-version": "vor", "intended-application": "text-mining" } ], "member": "78", "original-title": [], "page": "117535", "prefix": "10.1016", "published": { "date-parts": [ [ 2023, 12 ] ] }, "published-print": { "date-parts": [ [ 2023, 12 ] ] }, "publisher": "Elsevier BV", "reference": [ { "DOI": "10.3389/fphar.2020.578970", "article-title": "Indian medicinal plants and formulations and their potential against COVID-19–preclinical and clinical research", "author": "Ahmad", "doi-asserted-by": "crossref", "journal-title": "Front. Pharmacol.", "key": "10.1016/j.jep.2023.117535_bib1", "volume": "11", "year": "2021" }, { "DOI": "10.1016/j.phymed.2022.154136", "article-title": "Herbal medicine for COVID-19: an overview of systematic reviews and meta-analysis", "author": "Ang", "doi-asserted-by": "crossref", "journal-title": "Phytomedicine", "key": "10.1016/j.jep.2023.117535_bib2", "volume": "102", "year": "2022" }, { "author": "Ayurveda Pharmacopeia", "key": "10.1016/j.jep.2023.117535_bib3", "series-title": "Department of Ayurveda, Colombo. Sri Lanka", "year": "1976" }, { "DOI": "10.3390/biom10020202", "article-title": "Syzygium aromaticum L. (Myrtaceae): traditional uses, bioactive chemical constituents, pharmacological and toxicological activities", "author": "Batiha", "doi-asserted-by": "crossref", "first-page": "202", "issue": "2", "journal-title": "Biomolecules", "key": "10.1016/j.jep.2023.117535_bib4", "volume": "10", "year": "2020" }, { "author": "Bhisagratna", "key": "10.1016/j.jep.2023.117535_bib5", "series-title": "Bhaisajya Ratnāvali. Translated by K. Lochana", "year": "2008" }, { "DOI": "10.1016/S2213-2600(22)00011-X", "article-title": "The role of antiviral treatment in the COVID-19 pandemic", "author": "Burki", "doi-asserted-by": "crossref", "first-page": "e18", "issue": "2", "journal-title": "Lancet Respir. Med.", "key": "10.1016/j.jep.2023.117535_bib6", "volume": "10", "year": "2022" }, { "author": "Chang", "key": "10.1016/j.jep.2023.117535_bib7", "series-title": "Pharmacology and Applications of Chinese Materia Medica", "year": "1987" }, { "DOI": "10.1056/NEJMoa2029849", "article-title": "SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with covid-19", "author": "Chen", "doi-asserted-by": "crossref", "first-page": "229", "issue": "3", "journal-title": "N. Engl. J. Med.", "key": "10.1016/j.jep.2023.117535_bib8", "volume": "384", "year": "2020" }, { "author": "Dahanukar", "key": "10.1016/j.jep.2023.117535_bib9", "series-title": "Ayurveda Revisited", "year": "2000" }, { "DOI": "10.1016/j.metop.2021.100141", "article-title": "Herbal medicine use for the management of COVID-19: a review article", "author": "Demeke", "doi-asserted-by": "crossref", "journal-title": "Metabol Open", "key": "10.1016/j.jep.2023.117535_bib10", "volume": "12", "year": "2021" }, { "article-title": "Importance of Astavarga plants in traditional systems of medicine in Garhwal, Indian Himalaya", "author": "Dhyani", "first-page": "13", "issue": "1–2", "journal-title": "J. Biomol. Struct. Dyn. Ecosystem Services & Management", "key": "10.1016/j.jep.2023.117535_bib11", "volume": "6", "year": "2010" }, { "article-title": "Herb profile - Andrographis Andrographis paniculata", "author": "Engels", "first-page": "1", "journal-title": "HerbalGram", "key": "10.1016/j.jep.2023.117535_bib12", "volume": "105", "year": "2015" }, { "article-title": "Andrographolide as a potential inhibitor of SARS-CoV-2 main protease: an in-silico approach", "author": "Enmozhi", "first-page": "3092", "issue": "9", "journal-title": "J. Biomol. Struct. Dyn.", "key": "10.1016/j.jep.2023.117535_bib13", "volume": "39", "year": "2021" }, { "DOI": "10.1056/NEJMoa2118542", "article-title": "Oral nirmatrelvir for high-risk, nonhospitalized adults with covid-19", "author": "Hammond", "doi-asserted-by": "crossref", "first-page": "1397", "issue": "15", "journal-title": "N. Engl. J. Med.", "key": "10.1016/j.jep.2023.117535_bib14", "volume": "386", "year": "2022" }, { "DOI": "10.1007/s10787-017-0319-2", "article-title": "Inhibition of proinflammatory pathways by bioactive fraction of Tinospora cordifolia", "author": "Jacob", "doi-asserted-by": "crossref", "first-page": "531", "issue": "2", "journal-title": "Inflammopharmacology", "key": "10.1016/j.jep.2023.117535_bib15", "volume": "26", "year": "2018" }, { "DOI": "10.1056/NEJMoa2116044", "article-title": "Molnupiravir for oral treatment of covid-19 in nonhospitalized patients", "author": "Jayk Bernal", "doi-asserted-by": "crossref", "first-page": "509", "issue": "6", "journal-title": "N. Engl. J. Med.", "key": "10.1016/j.jep.2023.117535_bib16", "volume": "386", "year": "2021" }, { "DOI": "10.1016/j.jep.2021.113954", "article-title": "Andrographis paniculata (Burm.f.) Nees and its major constituent andrographolide as potential antiviral agents", "author": "Jiang", "doi-asserted-by": "crossref", "journal-title": "J. Ethnopharmacol.", "key": "10.1016/j.jep.2023.117535_bib17", "volume": "272", "year": "2021" }, { "article-title": "Andrographis paniculata: a review of its traditional uses, phytochemistry and pharmacology", "author": "Joselin", "first-page": "169", "journal-title": "Med. Aromatic Plants", "key": "10.1016/j.jep.2023.117535_bib18", "volume": "3", "year": "2014" }, { "DOI": "10.1039/D0RA10529E", "article-title": "Combination of system biology to probe the anti-viral activity of andrographolide and its derivative against COVID-19", "author": "Khanal", "doi-asserted-by": "crossref", "first-page": "5065", "issue": "9", "journal-title": "RSC Adv.", "key": "10.1016/j.jep.2023.117535_bib19", "volume": "11", "year": "2021" }, { "article-title": "Andrographis paniculata (Burm. F.) wall. Ex nees, andrographolide, and andrographolide analogues as SARS-CoV-2 antivirals? A rapid review", "author": "Lim", "issue": "5", "journal-title": "Nat. Prod. Commun.", "key": "10.1016/j.jep.2023.117535_bib20", "volume": "16", "year": "2021" }, { "DOI": "10.1038/s41579-022-00722-z", "article-title": "Antigenic evolution will lead to new SARS-CoV-2 variants with unpredictable severity", "author": "Markov", "doi-asserted-by": "crossref", "first-page": "251", "issue": "5", "journal-title": "Nat. Rev. Microbiol.", "key": "10.1016/j.jep.2023.117535_bib21", "volume": "20", "year": "2022" }, { "DOI": "10.1007/s13337-020-00598-8", "article-title": "Structure-based drug designing for potential antiviral activity of selected natural products from Ayurveda against SARS-CoV-2 spike glycoprotein and its cellular receptor", "author": "Maurya", "doi-asserted-by": "crossref", "first-page": "179", "issue": "2", "journal-title": "Virusdisease", "key": "10.1016/j.jep.2023.117535_bib22", "volume": "31", "year": "2020" }, { "key": "10.1016/j.jep.2023.117535_bib23", "series-title": "Discharge Criteria of COVID - 19 Patients Version III - (30-10-2020)", "year": "2020" }, { "key": "10.1016/j.jep.2023.117535_bib24", "series-title": "Revised Clinical Practice Guidelines on Institutional Management of COVID - 19 Patients in Sri Lanka -(25-05-2021", "year": "2021" }, { "DOI": "10.1016/j.ijid.2020.09.033", "article-title": "Hypokalemia as a sensitive biomarker of disease severity and the requirement for invasive mechanical ventilation requirement in COVID-19 pneumonia: a case series of 306 Mediterranean patients", "author": "Moreno-P", "doi-asserted-by": "crossref", "first-page": "449", "journal-title": "Int. J. Infect. Dis.", "key": "10.1016/j.jep.2023.117535_bib25", "volume": "100", "year": "2020" }, { "DOI": "10.3389/fimmu.2020.01239", "article-title": "Symptomatic protective action of glycyrrhizin (Licorice) in COVID-19 infection", "author": "Murck", "doi-asserted-by": "crossref", "first-page": "1239", "journal-title": "Front. Immunol.", "key": "10.1016/j.jep.2023.117535_bib26", "volume": "11", "year": "2020" }, { "article-title": "An ethnobotanical study of medicinal plants used by the tribes in upper subansiri district of Arunachal Pradesh, India", "author": "Murtem", "first-page": "35", "issue": "3", "journal-title": "Am. J. Ethnomed.", "key": "10.1016/j.jep.2023.117535_bib27", "volume": "3", "year": "2016" }, { "DOI": "10.1080/07391102.2020.1777901", "article-title": "Computational investigation on Andrographis paniculata phytochemicals to evaluate their potency against SARS-CoV-2 in comparison to known antiviral compounds in drug trials", "author": "Murugan", "doi-asserted-by": "crossref", "first-page": "4415", "issue": "12", "journal-title": "J. Biomol. Struct. Dyn.", "key": "10.1016/j.jep.2023.117535_bib28", "volume": "39", "year": "2020" }, { "author": "Pocock", "key": "10.1016/j.jep.2023.117535_bib29", "series-title": "Clinical Trials: a Practical Approach", "year": "1983" }, { "article-title": "Phytochemical 6-Gingerol – a promising Drug of choice for COVID-19", "author": "Rathinavel", "first-page": "1482", "issue": "4", "journal-title": "Int. J. Adv. Sci. Eng. Inf. Technol.", "key": "10.1016/j.jep.2023.117535_bib30", "volume": "6", "year": "2020" }, { "DOI": "10.3390/ph15081013", "article-title": "Efficacy of kan Jang® in patients with mild COVID-19: interim analysis of a randomized, quadruple-blind, placebo-controlled trial", "author": "Ratiani", "doi-asserted-by": "crossref", "first-page": "1013", "issue": "8", "journal-title": "Pharmaceuticals", "key": "10.1016/j.jep.2023.117535_bib31", "volume": "15", "year": "2022" }, { "DOI": "10.1056/NEJMoa2021436", "article-title": "Dexamethasone in hospitalized patients with covid-19", "doi-asserted-by": "crossref", "first-page": "693", "issue": "8", "journal-title": "N. Engl. J. Med.", "key": "10.1016/j.jep.2023.117535_bib32", "volume": "384", "year": "2021" }, { "author": "Sarangadhara", "key": "10.1016/j.jep.2023.117535_bib33", "series-title": "Sharangadhara Samhita. Translated by A. Kumarasingha", "year": "2007" }, { "DOI": "10.1136/bmjnph-2021-000375", "article-title": "Overweight and obesity as risk factors for COVID-19-associated hospitalisations and death: systematic review and meta-analysis", "author": "Sawadogo", "doi-asserted-by": "crossref", "first-page": "10", "issue": "1", "journal-title": "BMJ Nutr Prev Health", "key": "10.1016/j.jep.2023.117535_bib34", "volume": "5", "year": "2022" }, { "DOI": "10.1016/j.jep.2014.02.040", "article-title": "An ethnobotanical study of indigenous knowledge on medicinal plants used by the village peoples of Thoppampatti, Dindigul district, Tamilnadu, India", "author": "Sivasankari", "doi-asserted-by": "crossref", "first-page": "408", "issue": "2", "journal-title": "J. Ethnopharmacol.", "key": "10.1016/j.jep.2023.117535_bib35", "volume": "153", "year": "2014" }, { "article-title": "Ethnobotanical investigation of some medicinal plants availed by gond tribe of naoradehi wildlife sanctuary, Madhya Pradesh", "author": "Tiwari", "first-page": "201", "issue": "3", "journal-title": "Anthropol.", "key": "10.1016/j.jep.2023.117535_bib36", "volume": "5", "year": "2003" }, { "author": "Weragoda", "first-page": "71", "key": "10.1016/j.jep.2023.117535_bib37", "volume": "vol. 2", "year": "1980" }, { "key": "10.1016/j.jep.2023.117535_bib38", "series-title": "Obesity", "year": "2022" }, { "key": "10.1016/j.jep.2023.117535_bib39", "series-title": "WHO Coronavirus (COVID-19) Dashboard", "year": "2023" }, { "author": "Wujastyk", "key": "10.1016/j.jep.2023.117535_bib40", "series-title": "Modern and Global Ayurveda: Pluralism and Paradigms", "year": "2008" } ], "reference-count": 40, "references-count": 40, "relation": {}, "resource": { "primary": { "URL": "https://linkinghub.elsevier.com/retrieve/pii/S0378874123014058" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [ "Drug Discovery", "Pharmacology" ], "subtitle": [], "title": "Efficacy and safety of Link Natural Sudarshana, an Ayurvedic herbal preparation in COVID-19 patients: A phase II multicenter double-blind randomized placebo-controlled trial", "type": "journal-article", "update-policy": "http://dx.doi.org/10.1016/elsevier_cm_policy" }