Clinical toxicology study of a laxative herbal medicinal extract in healthy volunteers Celso H. Oliveira¹*, Maria Elisabete A. Moraes³, Manoel O. Moraes³, Fernando A. F. Be- zerra³, Karla F. Deud-José and Gilberto De Nucci² ¹ Department of Pediatrics of State University of Campinas, Campinas-SP, Brazil, ² Institute of Biomedical Sciences of State University of São Paulo, São Paulo-SP, Brazil, ³ Department of Pharmacology, Federal University of Ceará, Fortaleza-CE, Brazil, Phytopharm South America, Porto Alegre-RS, Brazil Background: In Brazil, an herbal medicinal extract named Olina® containing a mixture of Angelica archangelica (Angelica; Apiaceae), Alpinia ofcinarum (Lesser Galangal; Zingiberaceae), Commiph- ora myrrha (Myrrh; Burseraceae), Rheum palmatum (Chinese Rhubarb; Polygonaceae), Gentiana lutea (Yellow Gentian; Gentianaceae), Aloe ferox (Cape Aloe; Liliaceae) & Cinnamomum zeylanicum (Raw Cinnamon; Lauraceae) is used as a as a laxative and for treatment of dyspeptic symptoms. Purposes: The present study investigated the chronic administration of Olina® for any toxic effect on healthy volunteers. Methods: 15 mL Olina® was administered twice a day for 28 days to 24 healthy male volunteers. Results/Conclusion: No severe adverse reactions or hematological and biochemical changes were reported. Keywords: galangal, mirrh, Chinese rhubarb, cinnamon, yellow gentian, laxative Introduction There are several treatments for gastroin- testinal symptoms and diseases such as dyspepsia (chronic or recurrent pain in the upper abdomen), constipation (infrequent hard-to-pass bowel move- ments), and irritable bowel syndrome (functional bow- el disorder). Despite availability of allopathic drugs such as H2 antihistaminic blockers, proton inhibitors, laxatives and antispasmodics, herbal products are used more progressively in these treatments. An herbal extract of Angelica archangelica L. (An- gelica; Apiaceae), Alpinia ofcinarum Hance (Less- er Galangal; Zingiberaceae), Commiphora myrrha (Ness) Baillon (Myrrh; Burseraceae), Rheum palma- __________________________________________ *Correspondence: Celso Henrique de Oliveira, Av. Orosim- bo Maia, 570 – 51, 13010-918 Campinas-SP, Brazil, e- mail: oliveira_ch@terra.com.br ANM Journal (2010), 180 (2), 10-15. © 2010 The Authors tum L. (Chinese Rhubarb; Polygonaceae),Gentiana lutea L. (Yellow Gentian; Gentianaceae), Aloe ferox Miller (Cape Aloe; Liliaceae), and Cinnamomum zey- lanicum Blume (Raw Cinnamon; Lauraceae) named Olina® is commercially available in Brazil as a laxa- tive and for treatment of dyspeptic symptoms. There has been no toxicological study performed in humans on its side effects. Olina® herbal extract compounds have been traditionally used used in a variety of medica- tioin. Furthermore, several herbal extracts present in the Olina® extract such as Angelica root extract, Galangal dried rhizome extract, Chinese Rhubarb root extract, and dried Yellow Gentian or fresh un- derground plant organs have been approved by the- German Commission E (Blumenthal et al., 1998). These herbal extracts are approved to increase appetite, for dyspeptic complaints, and constipa- tion treatment (Blumenthal et al., 1998). In addition, 4 4