Ashwagandha, Withania somnifera (L.) Dunal, for the prophylaxis against SARS-CoV-2 infection: A multicentric randomized hydroxychloroquine controlled clinical trial in Indian health care workers

DOI record: { "DOI": "10.1016/j.jaim.2025.101135", "ISSN": [ "0975-9476" ], "URL": "http://dx.doi.org/10.1016/j.jaim.2025.101135", "alternative-id": [ "S0975947625000117" ], "article-number": "101135", "assertion": [ { "label": "This article is maintained by", "name": "publisher", "value": "Elsevier" }, { "label": "Article Title", "name": "articletitle", "value": "Ashwagandha, Withania somnifera (L.) Dunal, for the prophylaxis against SARS-CoV-2 infection: A multicentric randomized hydroxychloroquine controlled clinical trial in Indian health care workers" }, { "label": "Journal Title", "name": "journaltitle", "value": "Journal of Ayurveda and Integrative Medicine" }, { "label": "CrossRef DOI link to publisher maintained version", "name": "articlelink", "value": "https://doi.org/10.1016/j.jaim.2025.101135" }, { "label": "Content Type", "name": "content_type", "value": "article" }, { "label": "Copyright", "name": "copyright", "value": "© 2025 CSIR-Indian Institute of Integrative Medicine. Published by Elsevier B.V. on behalf of Institute of Transdisciplinary Health Science and Technology and World Ayurveda Foundation." } ], "author": [ { "affiliation": [], "family": "Kulkarni-Munshi", "given": "Renuka", "sequence": "first" }, { "affiliation": [], "family": "Talmohite", "given": "Deepti", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-9706-7046", "affiliation": [], "authenticated-orcid": false, "family": "More", "given": "Anand", "sequence": "additional" }, { "affiliation": [], "family": "Chakravarty", "given": "Jaya", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-7464-5608", "affiliation": [], "authenticated-orcid": false, "family": "Kamat", "given": "Sandhya", "sequence": "additional" }, { "affiliation": [], "family": "Khobragade", "given": "Akash", "sequence": "additional" }, { "affiliation": [], "family": "Reddy", "given": "D. Himanshu", "sequence": "additional" }, { "affiliation": [], "family": "Patel", "given": "Manish", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0003-3571-5578", "affiliation": [], "authenticated-orcid": false, "family": "Kajaria", "given": "Divya", "sequence": "additional" }, { "affiliation": [], "family": "Singh", "given": "Raju", "sequence": "additional" }, { "affiliation": [], "family": "Kumari", "given": "Sarita", "sequence": "additional" }, { "affiliation": [], "family": "Mishra", "given": "Priyanka", "sequence": "additional" }, { "affiliation": [], "family": "Srivastava", "given": "A.K.", "sequence": "additional" }, { "affiliation": [], "family": "Bhagat", "given": "Vivek", "sequence": "additional" }, { "affiliation": [], "family": "Pandey", "given": "Saurabh", "sequence": "additional" }, { "affiliation": [], "family": "Yadav", "given": "Meena", "sequence": "additional" }, { "affiliation": [], "family": "Darnule", "given": "Rahul", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0003-4460-3324", "affiliation": [], "authenticated-orcid": false, "family": "Bhat", "given": "Shobha", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0001-5866-5724", "affiliation": [], "authenticated-orcid": false, "family": "Kansal", "given": "Sangeeta", "sequence": "additional" }, { "affiliation": [], "family": "Munot", "given": "Sonali", "sequence": "additional" }, { "affiliation": [], "family": "Kumbhar", "given": "Dipti", "sequence": "additional" }, { "affiliation": [], "family": "Tripathi", "given": "Raakhi", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-0358-1600", "affiliation": [], "authenticated-orcid": false, "family": "Gajbhiye", "given": "Snehalata", "sequence": "additional" }, { "affiliation": [], "family": "Marathe", "given": "Padmaja", "sequence": "additional" }, { "affiliation": [], "family": "Parvatkar", "given": "Jaee", "sequence": "additional" }, { "affiliation": [], "family": "Shukla", "given": "Dhaiwat", "sequence": "additional" }, { "affiliation": [], "family": "Panchal", "given": "Prakashkumar", "sequence": "additional" }, { "affiliation": [], "family": "Shah", "given": "Jui", "sequence": "additional" }, { "affiliation": [], "family": "Bhale", "given": "Jayashree", "sequence": "additional" }, { "affiliation": [], "family": "Sattigeri", "given": "Viswajanani", "sequence": "additional" }, { "affiliation": [], "family": "Amarsheda", "given": "Ashish", "sequence": "additional" }, { "affiliation": [], "family": "Avhad", "given": "Anil", "sequence": "additional" }, { "affiliation": [], "family": "Kshirsagar", "given": "Nilima", "sequence": "additional" }, { "ORCID": "https://orcid.org/0009-0003-3744-2945", "affiliation": [], "authenticated-orcid": false, "family": "Mondhe", "given": "Dilip M.", "sequence": "additional" }, { "affiliation": [], "family": "Chopra", "given": "Arvind", "sequence": "additional" } ], "container-title": "Journal of Ayurveda and Integrative Medicine", "container-title-short": "Journal of Ayurveda and Integrative Medicine", "content-domain": { "crossmark-restriction": true, "domain": [ "clinicalkey.com", "clinicalkey.com.au", "clinicalkey.fr", "clinicalkey.jp", "elsevier.com", "sciencedirect.com" ] }, "created": { "date-parts": [ [ 2025, 6, 6 ] ], "date-time": "2025-06-06T18:41:46Z", "timestamp": 1749235306000 }, "deposited": { "date-parts": [ [ 2025, 6, 7 ] ], "date-time": "2025-06-07T02:04:30Z", "timestamp": 1749261870000 }, "indexed": { "date-parts": [ [ 2025, 6, 7 ] ], "date-time": "2025-06-07T04:08:30Z", "timestamp": 1749269310900, "version": "3.41.0" }, "is-referenced-by-count": 0, "issue": "3", "issued": { "date-parts": [ [ 2025, 5 ] ] }, "journal-issue": { "issue": "3", "published-print": { "date-parts": [ [ 2025, 5 ] ] } }, "language": "en", "license": [ { "URL": "https://www.elsevier.com/tdm/userlicense/1.0/", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 5, 1 ] ], "date-time": "2025-05-01T00:00:00Z", "timestamp": 1746057600000 } }, { "URL": "https://www.elsevier.com/legal/tdmrep-license", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 5, 1 ] ], "date-time": "2025-05-01T00:00:00Z", "timestamp": 1746057600000 } }, { "URL": "http://creativecommons.org/licenses/by-nc-nd/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 2, 11 ] ], "date-time": "2025-02-11T00:00:00Z", "timestamp": 1739232000000 } } ], "link": [ { "URL": "https://api.elsevier.com/content/article/PII:S0975947625000117?httpAccept=text/xml", "content-type": "text/xml", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://api.elsevier.com/content/article/PII:S0975947625000117?httpAccept=text/plain", "content-type": "text/plain", "content-version": "vor", "intended-application": "text-mining" } ], "member": "78", "original-title": [], "page": "101135", "prefix": "10.1016", "published": { "date-parts": [ [ 2025, 5 ] ] }, "published-print": { "date-parts": [ [ 2025, 5 ] ] }, "publisher": "Elsevier BV", "reference": [ { "article-title": "An overview on ashwagandha: a Rasayana (rejuvenator) of Ayurveda", "author": "Singh", "first-page": "208", "issue": "5 Suppl", "journal-title": "Afr J Tradit, Complementary Altern Med", "key": "10.1016/j.jaim.2025.101135_bib1", "volume": "8", "year": "2011" }, { "DOI": "10.3389/fphar.2021.623795", "article-title": "Withania somnifera (L.) Dunal: opportunity for clinical repurposing in COVID-19 management", "author": "Saggam", "doi-asserted-by": "crossref", "first-page": "835", "journal-title": "Front Pharmacol", "key": "10.1016/j.jaim.2025.101135_bib2", "volume": "12", "year": "2021" }, { "DOI": "10.1016/j.jep.2021.114101", "article-title": "Rational use of ashwagandha in Ayurveda (traditional Indian medicine) for health and healing", "author": "Joshi", "doi-asserted-by": "crossref", "journal-title": "J Ethnopharmacol", "key": "10.1016/j.jaim.2025.101135_bib3", "volume": "276", "year": "2021" }, { "DOI": "10.1016/j.hermed.2021.100434", "article-title": "Ashwagandha (Withania somnifera) for the treatment and enhancement of mental and physical conditions: a systematic review of human trials", "author": "Lopresti", "doi-asserted-by": "crossref", "journal-title": "J Herb Med", "key": "10.1016/j.jaim.2025.101135_bib4", "volume": "28", "year": "2021" }, { "article-title": "Biological activity of withanolides", "author": "Budhiraja", "first-page": "904", "journal-title": "J Sci Ind Res", "key": "10.1016/j.jaim.2025.101135_bib5", "volume": "59", "year": "2000" }, { "DOI": "10.3390/pharmaceutics14030611", "article-title": "Withania somnifera: progress towards a pharmaceutical agent for immunomodulation and cancer therapeutics", "author": "Kashyap", "doi-asserted-by": "crossref", "first-page": "611", "issue": "3", "journal-title": "Pharmaceutics", "key": "10.1016/j.jaim.2025.101135_bib6", "volume": "14", "year": "2022" }, { "article-title": "Therapeutic uses of Withania somnifera (Ashwagandha) with a note on withanolides and its pharmacological actions", "author": "Verma", "first-page": "1", "issue": "1", "journal-title": "Asian J Pharmaceut Clin Res", "key": "10.1016/j.jaim.2025.101135_bib7", "volume": "4", "year": "2011" }, { "article-title": "Scientific basis for the therapeutic use of Withania somnifera (ashwagandha): a review", "author": "Mishra", "first-page": "334", "issue": "4", "journal-title": "Alternative Med Rev", "key": "10.1016/j.jaim.2025.101135_bib8", "volume": "5", "year": "2000" }, { "article-title": "Withania somnifera (Ashwagandha): a review", "author": "Gupta", "issue": "1", "journal-title": "Pharmacogn Rev", "key": "10.1016/j.jaim.2025.101135_bib9", "volume": "1", "year": "2007" }, { "DOI": "10.4103/0253-7176.106022", "article-title": "A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults", "author": "Chandrasekhar", "doi-asserted-by": "crossref", "first-page": "255", "issue": "3", "journal-title": "Indian J Psychol Med", "key": "10.1016/j.jaim.2025.101135_bib10", "volume": "34", "year": "2012" }, { "article-title": "A standardized Withania somnifera extract significantly reduces stress related parameters in chronically stressed humans: a double blind, randomized, placebo-controlled study", "author": "Auddy", "first-page": "50", "journal-title": "JANA", "key": "10.1016/j.jaim.2025.101135_bib11", "volume": "11", "year": "2008" }, { "DOI": "10.1089/acm.2014.0177", "article-title": "An alternative treatment for anxiety: a systematic review of human trial results reported for the Ayurvedic herb ashwagandha (Withania somnifera)", "author": "Pratte", "doi-asserted-by": "crossref", "first-page": "901", "issue": "12", "journal-title": "J Alternative Compl Med", "key": "10.1016/j.jaim.2025.101135_bib12", "volume": "20", "year": "2014" }, { "DOI": "10.1016/0378-8741(95)01318-0", "article-title": "Studies on the immunomodulatory effects of Ashwagandha", "author": "Ziauddin", "doi-asserted-by": "crossref", "first-page": "69", "issue": "2", "journal-title": "J Ethnopharmacol", "key": "10.1016/j.jaim.2025.101135_bib13", "volume": "50", "year": "1996" }, { "DOI": "10.1155/2013/571420", "article-title": "Clinical evaluation of the spermatogenic activity of the root extract of Ashwagandha (Withania somnifera) in oligospermic males: a pilot study", "author": "Ambiye", "doi-asserted-by": "crossref", "first-page": "1", "journal-title": "Evid Based Complement Alternat Med", "key": "10.1016/j.jaim.2025.101135_bib15", "volume": "2013", "year": "2013" }, { "DOI": "10.1177/1534735412464551", "article-title": "Effect of Withania somnifera (Ashwagandha) on the development of chemotherapy-induced fatigue and quality of life in breast cancer patients", "author": "Biswal", "doi-asserted-by": "crossref", "first-page": "312", "issue": "4", "journal-title": "Integr Cancer Ther", "key": "10.1016/j.jaim.2025.101135_bib16", "volume": "12", "year": "2013" }, { "DOI": "10.4088/JCP.17m11826", "article-title": "Adjunctive use of a standardized extract of Withania somnifera (Ashwagandha) to treat symptom exacerbation in schizophrenia: a randomized, double-blind, placebo-controlled study", "author": "Chengappa", "doi-asserted-by": "crossref", "issue": "5", "journal-title": "J Clin Psychiatry", "key": "10.1016/j.jaim.2025.101135_bib17", "volume": "79", "year": "2018" }, { "DOI": "10.1007/s10067-011-1809-z", "article-title": "Comparable efficacy of standardized Ayurveda formulation and hydroxychloroquine sulfate (HCQS) in the treatment of rheumatoid arthritis (RA): a randomized investigator-blind controlled study", "author": "Chopra", "doi-asserted-by": "crossref", "first-page": "259", "issue": "2", "journal-title": "Clin Rheumatol", "key": "10.1016/j.jaim.2025.101135_bib18", "volume": "31", "year": "2012" }, { "DOI": "10.1177/2156587216641830", "article-title": "Body weight management in adults under chronic stress through treatment with ashwagandha root extract: a double-blind, randomized, placebo-controlled trial", "author": "Choudhary", "doi-asserted-by": "crossref", "first-page": "96", "issue": "1", "journal-title": "J Evid Based Complementary Altern Med", "key": "10.1016/j.jaim.2025.101135_bib19", "volume": "22", "year": "2017" }, { "DOI": "10.1080/19390211.2017.1284970", "article-title": "Efficacy and safety of Ashwagandha (Withania somnifera (L.) Dunal) root extract in improving memory and cognitive functions", "author": "Choudhary", "doi-asserted-by": "crossref", "first-page": "599", "issue": "6", "journal-title": "J Diet Suppl", "key": "10.1016/j.jaim.2025.101135_bib20", "volume": "14", "year": "2017" }, { "DOI": "10.1016/j.sleep.2020.03.012", "article-title": "A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults", "author": "Deshpande", "doi-asserted-by": "crossref", "first-page": "28", "journal-title": "Sleep Med", "key": "10.1016/j.jaim.2025.101135_bib21", "volume": "72", "year": "2020" }, { "DOI": "10.1155/2015/284154", "article-title": "Efficacy and safety of Ashwagandha (Withania somnifera) root extract in improving sexual function in women: a pilot study", "author": "Dongre", "doi-asserted-by": "crossref", "first-page": "1", "journal-title": "BioMed Res Int", "key": "10.1016/j.jaim.2025.101135_bib22", "volume": "2015", "year": "2015" }, { "article-title": "Effects of a standardized extract of Withania somnifera (Ashwagandha) on depression and anxiety symptoms in persons with schizophrenia participating in a randomized, placebo-controlled clinical trial", "author": "Gannon", "first-page": "123", "issue": "2", "journal-title": "Ann Clin Psychiatr", "key": "10.1016/j.jaim.2025.101135_bib23", "volume": "31", "year": "2019" }, { "article-title": "Efficacy and safety of Ashwagandha (Withania somnifera) root extract in insomnia and anxiety: a double-blind, randomized, placebo-controlled study", "author": "Langade", "issue": "9", "journal-title": "Cureus", "key": "10.1016/j.jaim.2025.101135_bib24", "volume": "11", "year": "2019" }, { "DOI": "10.1097/MD.0000000000017186", "article-title": "An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: a randomized, double-blind, placebo-controlled study", "author": "Lopresti", "doi-asserted-by": "crossref", "issue": "37", "journal-title": "Medicine", "key": "10.1016/j.jaim.2025.101135_bib25", "volume": "98", "year": "2019" }, { "DOI": "10.4103/0974-7788.72485", "article-title": "Effects of Withania somnifera (Ashwagandha) and Terminalia arjuna (Arjuna) on physical performance and cardiorespiratory endurance in healthy young adults", "author": "Sandhu", "doi-asserted-by": "crossref", "first-page": "144", "issue": "3", "journal-title": "Int J Ayurveda Res", "key": "10.1016/j.jaim.2025.101135_bib26", "volume": "1", "year": "2010" }, { "DOI": "10.1089/acm.2017.0183", "article-title": "Efficacy and safety of ashwagandha root extract in subclinical hypothyroid patients: a double-blind, randomized placebo-controlled trial", "author": "Sharma", "doi-asserted-by": "crossref", "first-page": "243", "issue": "3", "journal-title": "J Alternative Compl Med", "key": "10.1016/j.jaim.2025.101135_bib27", "volume": "24", "year": "2018" }, { "article-title": "The comparative effect of milk fortified with Aswagandha, Aswagandha and Punarnava in children-a double-blind study", "author": "Venkataraghavan", "first-page": "370", "journal-title": "J Res Ayur Sid", "key": "10.1016/j.jaim.2025.101135_bib28", "volume": "1", "year": "1980" }, { "DOI": "10.1186/s12970-015-0104-9", "article-title": "Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial", "author": "Wankhede", "doi-asserted-by": "crossref", "first-page": "43", "issue": "12", "journal-title": "J Int Soc Sports Nutr", "key": "10.1016/j.jaim.2025.101135_bib29", "year": "2015" }, { "DOI": "10.1016/S0378-8741(99)00065-3", "article-title": "Studies on immunomodulatory activity of Withania somnifera (Ashwagandha) extracts in experimental immune inflammation", "author": "Agarwal", "doi-asserted-by": "crossref", "first-page": "27", "issue": "1", "journal-title": "J Ethnopharmacol", "key": "10.1016/j.jaim.2025.101135_bib30", "volume": "67", "year": "1999" }, { "DOI": "10.2174/1871523017666181116092934", "article-title": "In vivo, extract from Withania somnifera root ameliorates arthritis via regulation of key immune mediators of inflammation in experimental model of arthritis", "author": "Khan", "doi-asserted-by": "crossref", "first-page": "55", "issue": "1", "journal-title": "Antiinflamm Antiallergy Agents Med Chem", "key": "10.1016/j.jaim.2025.101135_bib31", "volume": "18", "year": "2019" }, { "DOI": "10.1016/j.ctim.2021.102768", "article-title": "Withania somnifera as a safer option to hydroxychloroquine in the chemoprophylaxis of COVID-19: results of interim analysis", "author": "Chopra", "doi-asserted-by": "crossref", "journal-title": "Compl Ther Med", "key": "10.1016/j.jaim.2025.101135_bib32", "volume": "62", "year": "2021" }, { "article-title": "Hydroxychloroquine for SARS CoV2 prophylaxis in healthcare workers-A multicentric cohort study assessing effectiveness and safety", "author": "Dinesh", "first-page": "11", "issue": "6", "journal-title": "J Assoc Phys India", "key": "10.1016/j.jaim.2025.101135_bib33", "volume": "69", "year": "2021" }, { "DOI": "10.1080/14787210.2021.1828062", "article-title": "Use of hydroxychloroquine for pre-exposure prophylaxis in COVID 19: debate and suggested future course", "author": "Agarwal", "doi-asserted-by": "crossref", "first-page": "413", "issue": "4", "journal-title": "Expert Rev Anti Infect Ther", "key": "10.1016/j.jaim.2025.101135_bib34", "volume": "19", "year": "2021" }, { "DOI": "10.4103/ijmr.IJMR_2294_20", "article-title": "Safety of hydroxychloroquine in healthcare workers for COVID-19 prophylaxis", "author": "Faruqui", "doi-asserted-by": "crossref", "first-page": "219", "issue": "1–2", "journal-title": "Indian J Med Res", "key": "10.1016/j.jaim.2025.101135_bib35", "volume": "153", "year": "2021" }, { "DOI": "10.4103/0975-9476.100168", "article-title": "Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers", "author": "Raut", "doi-asserted-by": "crossref", "first-page": "111", "issue": "3", "journal-title": "J Ayurveda Integr Med", "key": "10.1016/j.jaim.2025.101135_bib36", "volume": "3", "year": "2012" }, { "DOI": "10.1016/j.ctim.2020.102642", "article-title": "Safety of ashwagandha root extract: a randomized, placebo-controlled, study in healthy volunteers", "author": "Verma", "doi-asserted-by": "crossref", "journal-title": "Compl Ther Med", "key": "10.1016/j.jaim.2025.101135_bib37", "volume": "57", "year": "2021" } ], "reference-count": 36, "references-count": 36, "relation": {}, "resource": { "primary": { "URL": "https://linkinghub.elsevier.com/retrieve/pii/S0975947625000117" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "title": "Ashwagandha, Withania somnifera (L.) Dunal, for the prophylaxis against SARS-CoV-2 infection: A multicentric randomized hydroxychloroquine controlled clinical trial in Indian health care workers", "type": "journal-article", "update-policy": "https://doi.org/10.1016/elsevier_cm_policy", "volume": "16" }