{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T18:31:12Z","timestamp":1788805872837,"version":"build-2803163510"},"reference-count":59,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T00:00:00Z","timestamp":1759881600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T00:00:00Z","timestamp":1759881600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Phytotherapy Research"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Ashwagandha, an adaptogen, is an important herb of Ayurveda used as a Rasayana for its various health benefits. This prospective, multi\u2010center, observational clinical study evaluates the safety (clinical and laboratory) of a standardized Ashwagandha Root Extract (ARE) on long\u2010term administration over 12\u2009months. Male and female adults (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u2009191) aged between 18 and 65\u2009years were included in the study. Clinical assessments were done at baseline, followed by monthly for 12\u2009months, whereas laboratory and other study assessments were done at baseline, 6 and 12\u2009months. The primary outcome was the clinical adverse events reported by the patients, whereas secondary outcomes were Clinical Global Impression\u2014Improvement scale (CGI\u2010I), health\u2010related Short Form\u201012 Quality of Life (SF\u201012 QoL), and laboratory estimations of serum for cortisol, hepatic, renal, and thyroid function. ARE administration for 12\u2009months reported 18 mild adverse events, which were resolved without intervention. The study reported no clinical significant changes in serum alanine transaminases (baseline: 31.31\u2009\u00b1\u20099.28\u2009\n                    <jats:styled-content style=\"fixed-case\">IU<\/jats:styled-content>\n                    \/L, end of study: 33.68\u2009\u00b1\u20096.80\u2009\n                    <jats:styled-content style=\"fixed-case\">IU<\/jats:styled-content>\n                    \/L), aspartate transaminases (baseline: 30.61\u2009\u00b1\u20097.18\u2009IU\/L, end of study: 29.02\u2009\u00b1\u20094.63\u2009IU\/L). Serum cortisol levels decreased significantly (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001), while lipid profile and plasma glucose levels remained unaffected. Serum testosterone (free and total) significantly increased (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.05).\n                    <jats:styled-content style=\"fixed-case\">SF<\/jats:styled-content>\n                    \u201012 scores demonstrated significant improvements at 12 months (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001), indicating enhanced health\u2010related quality of life.\n                    <jats:styled-content style=\"fixed-case\">CGI<\/jats:styled-content>\n                    assessment indicated overall improvement in 68.7% of patients, particularly notable in those aged \u2265\u200950\u2009years. This study validates the long\u2010term safety of\n                    <jats:styled-content style=\"fixed-case\">ARE<\/jats:styled-content>\n                    use over 12\u2009months.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ptr_70096.docx\">ClinicalTrials.gov<\/jats:ext-link>\n                    identifier: CTRI\/2022\/10\/046180; NCT06244147.\n                  <\/jats:p>","DOI":"10.1002\/ptr.70096","type":"journal-article","created":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T04:38:07Z","timestamp":1759984687000},"page":"4802-4812","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Safety of 12\u2010Months Administration of Ashwagandha (\n                    <scp>\n                      <i>Withania somnifera<\/i>\n                    <\/scp>\n                    ) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study"],"prefix":"10.1002","volume":"40","author":[{"given":"Jaising","family":"Salve","sequence":"first","affiliation":[{"name":"Prakruti Care Hospital  Thane India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjeev","family":"Kale","sequence":"additional","affiliation":[{"name":"D. Y. Patil University School of Medicine  Navi Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Banwari Lal","family":"Prajapati","sequence":"additional","affiliation":[{"name":"CLINI\u2010TON Multispeciality Clinic  Jaipur Rajasthan India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adele","family":"Sparavigna","sequence":"additional","affiliation":[{"name":"DERMING SRL Institute of Clinical Research and Bioengineering  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Savant","sequence":"additional","affiliation":[{"name":"San Francisco Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Ademola","sequence":"additional","affiliation":[{"name":"San Francisco Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepak","family":"Langade","sequence":"additional","affiliation":[{"name":"D. Y. Patil University School of Medicine  Navi Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,8]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1191\/0960327105ht509oa"},{"issue":"10","key":"e_1_2_11_3_1","article-title":"Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract for Improvement of Sexual Health in Healthy Women: A Prospective, Randomized, Placebo\u2010Controlled Study","volume":"14","author":"Ajgaonkar A.","year":"2022","journal-title":"Cureus"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6882-11-65"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1155\/2013\/571420"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.22159\/ijpps.2018v10i12.29493"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.14393"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.4103\/0253-7176.106022"},{"key":"e_1_2_11_9_1","article-title":"Neuroprotective Role of Withania somnifera Root Extract in Reserpine\u2010Induced Model of Parkinson's Disease: A Biochemical, Behavioral, and Histopathological Study","volume":"162","author":"Chaudhary A.","year":"2023","journal-title":"Biomedicine & Pharmacotherapy"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/hsr2.741"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/ehjqcco\/qcac060"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/19390211.2017.1284970"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejsc.12265"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules26123696"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.2478\/pjst-2023-0022"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1155\/2015\/284154"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules28031208"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.5281\/zenodo.10807262"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/jog.15030"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1155\/2021\/8254344"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.3390\/brainsci11070919"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.toxrep.2023.09.004"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.toxrep.2023.12.005"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1080\/02791072.2024.2424279"},{"issue":"6","key":"e_1_2_11_25_1","first-page":"58","article-title":"Analysis of Clinical Trial Registry of India for Evidence of Anti\u2010Arthritic Properties of \n                     Withania somnifera\n                   (Ashwagandha)","volume":"27","author":"Kanjilal S.","year":"2021","journal-title":"Alternative Therapies in Health and Medicine"},{"issue":"2","key":"e_1_2_11_26_1","article-title":"Efficacy and Tolerability of Ashwagandha Root Extract in the Elderly for Improvement of General Well\u2010Being and Sleep: A Prospective, Randomized, Double\u2010Blind, Placebo\u2010Controlled Study","volume":"12","author":"Kelgane S. 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