Safety Evaluation of a Standardized Dalbergia sissoo Leaf Extract (DSLE)

Pharmacognosy Research,2022,14,2,172-180.DOI:10.5530/pres.14.2.25Published:April 2022Type:Original ArticleAuthors:Tejal Gandhi, Hital Shah, Ritu Trivedi, Amol Deshmukh, and Lal Hingorani Author(s) affiliations:Tejal Gandhi1,*, Shah2, Trivedi3, Deshmukh4, Hingorani4 1Department of Pharmacology, Anand Pharmacy College, Anand, Gujarat, INDIA. 2Anand 3Endocrinology Division Biological South Block, Central Drug Research Institute, Uttar Pradesh, 4Pharmanza Herbals Pvt. Ltd., Dharmaj, Abstract:Background: Dalbergia sissoo, also known as Indian Rosewood, is a plant for its medicinal value with the leaves used traditionally effect on joint inflammation pain. Recently, sissoo derived novel compound Caviunin glycoside (CAFG) was shown to alleviate symptoms signs osteoarthritis in rat model. Objectives: The objective study investigate potential adverse effects, if any, standardized leaf extract (DSLE) rats following sub-chronic administration. Materials Methods: DSLE composition not less than 2% w/w CAFG 6% total flavonoids. In study, Wistar (10/sex/group) were administered via gavage 0 (control), 310, 620, 1240 mg/kg body weight/day 90 days. Two additional groups received 1240mg/kg /day days, followed by 28-day reversal phase. Results: revealed that administration did result any toxicologically significant treatment related changes clinical observation, ophthalmic examination, weight, weight gain, feed consumption, pathology organ weight. haematology serum chemistry parameters compared control group within normal laboratory limits. Terminal necroscopy indicate gross or histopathological findings. results genotoxicity studies evaluated gene mutations Salmonella typhimurium, vitro chromosome aberration assay reveal extract. Conclusion: Based this no observed-adverse-effect level (NOAEL) determined weight/day, highest dose tested. Key words: Dietary ingredient, Leaf extract, Safety, Toxicity, Sissoo, Bone health. View:PDF (318.13 KB)