{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T20:20:24Z","timestamp":1777666824179,"version":"3.51.4"},"reference-count":22,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2008,10,1]],"date-time":"2008-10-01T00:00:00Z","timestamp":1222819200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hum Exp Toxicol"],"published-print":{"date-parts":[[2008,10]]},"abstract":"<jats:p>A liquid alcoholic extract of Papaver somniferum named Elixir Paregorico\u00ae is extensively used for diarrheal diseases in Brazil. Its increased popularity has brought concerns and fears over the safety of this herbal product. Given the lack of investigative clinical studies, in this regard, this study investigated whether Elixir Paregorico\u00ae administration causes any noticeable toxic effects in healthy volunteers. In all, 28 middle-aged healthy male ( n\u00a0=\u00a014) and female ( n\u00a0=\u00a014) were enrolled. After screening and a washout period, eligible subjects received four oral doses per day of Elixir Paregorico\u00ae (3\u00a0mL diluted in 30\u00a0mL of water) over a 10-day period. Altogether, all 28 participants completed the study. The results of hematological and biochemical tests performed pre and post-treatment were within the normal range. In both male and female volunteers, there were no statistical differences ( P\u00a0&gt;\u00a00.05) in the results of clinical and laboratory tests performed at screening, on 5th and 10th day visits, and at final assessment. Although mild adverse events were related, which subsided spontaneously, no serious untoward reactions were reported following Elixir Paregorico\u00ae administration. To our knowledge, this is the first demonstration that Elixir Paregorico\u00ae administered four times a day for 10\u00a0days is safe and does not cause any noticeable toxic effect in healthy volunteers.<\/jats:p>","DOI":"10.1177\/0960327108090274","type":"journal-article","created":{"date-parts":[[2008,11,28]],"date-time":"2008-11-28T08:12:31Z","timestamp":1227859951000},"page":"751-756","source":"Crossref","is-referenced-by-count":9,"title":["Safety evaluation of Elixir paregorico\u00ae in healthy volunteers: a phase I study"],"prefix":"10.1177","volume":"27","author":[{"given":"MEA","family":"de Moraes","sequence":"first","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"MM","family":"Bezerra","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"FAF","family":"Bezerra","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"RA","family":"de Moraes","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"PP","family":"Cavalcanti","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"CRA","family":"Uchoa","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"FAV","family":"Lima","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"Odorico de Moraes","sequence":"additional","affiliation":[{"name":"Department of Physiology and Pharmacology, Faculty of Medicine, Clinical Pharmacology Unit, Federal University of Cear\u00e1, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2008,10,1]]},"reference":[{"key":"atypb1","doi-asserted-by":"publisher","DOI":"10.1016\/S0045-6535(03)00471-5"},{"key":"atypb2","doi-asserted-by":"publisher","DOI":"10.1002\/1099-1573(200009)14:6<401::AID-PTR762>3.0.CO;2-H"},{"key":"atypb3","doi-asserted-by":"publisher","DOI":"10.1002\/ptr.1484"},{"key":"atypb4","doi-asserted-by":"publisher","DOI":"10.1016\/j.phymed.2003.11.002"},{"key":"atypb5","doi-asserted-by":"publisher","DOI":"10.1016\/j.phymed.2007.03.010"},{"key":"atypb6","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199651050-00002"},{"key":"atypb7","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-540-33823-9_2"},{"key":"atypb8","doi-asserted-by":"publisher","DOI":"10.1007\/BF00449683"},{"key":"atypb9","volume-title":"Therapeutic drugs.","author":"Dollery CT","year":"1999"},{"key":"atypb10","first-page":"1347","volume":"74","author":"Swegle JM","year":"2006","journal-title":"Am Fam Physician"},{"key":"atypb11","doi-asserted-by":"publisher","DOI":"10.1016\/j.jep.2007.03.007"},{"key":"atypb12","doi-asserted-by":"publisher","DOI":"10.1016\/j.jep.2007.08.004"},{"key":"atypb13","doi-asserted-by":"publisher","DOI":"10.1177\/000992288402300207"},{"key":"atypb14","doi-asserted-by":"publisher","DOI":"10.1191\/096032799678839491"},{"key":"atypb15","first-page":"7","volume":"82","author":"Brazilian IV","year":"2004","journal-title":"Arq Bras Cardiol"},{"key":"atypb16","first-page":"618","volume":"31","author":"de Siqueira ME","year":"1997","journal-title":"J Public Health"},{"key":"atypb17","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-198800364-00007"},{"key":"atypb18","first-page":"58","volume":"29","author":"Riveron Corteguera RL","year":"1993","journal-title":"Archivos Dominicanos de Pediatria"},{"key":"atypb19","doi-asserted-by":"publisher","DOI":"10.1093\/heapol\/12.2.122"},{"key":"atypb20","doi-asserted-by":"publisher","DOI":"10.1196\/annals.1371.082"},{"key":"atypb21","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-198800364-00005"},{"key":"atypb22","doi-asserted-by":"publisher","DOI":"10.1016\/S0025-7125(16)30216-4"}],"container-title":["Human &amp; 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