AUTHOR=Balkrishna Acharya , Haldar Swati , Varshney Anurag 

TITLE=OECD-407 Driven 28-day-repeated-dose non-clinical safety evaluation of Tinospora cordifolia (Giloy) stem aqueous extract in Sprague-Dawley rats under GLP compliance

JOURNAL=Frontiers in Pharmacology

VOLUME=14

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1095083

DOI=10.3389/fphar.2023.1095083

ISSN=1663-9812

ABSTRACT=<p><bold>Introduction:</bold><italic>Tinospora cordifolia</italic> (Wild.) Hook.f. &amp; Thomson (Giloy), has been widely used in the Ayurvedic system of medicine. However, some sporadic under-powered case studies have recently reported <italic>Tinospora cordifolia</italic> associated toxicity. Thus, following OECD 407 guidelines, a 28-day-repeated-dose-14-day-recovery toxicological evaluation of the aqueous extract of <italic>T. cordifolia</italic> stem (TCWE) was conducted under good laboratory practice (GLP), in Sprague-Dawley (SD) rats.</p><p><bold>Methods:</bold> 100, 300, and 1000 mg/kg/day of TCWE was given orally to designated treatment groups of either sex. Two separate 14-day recovery satellite groups received either vehicle control or 1000 mg/kg/day of TCWE.</p><p><bold>Results:</bold> In this study, TCWE was found safe up to a dose of 1000 mg/kg/day with no mortality or related toxicological manifestation in terms of clinical signs, ocular effects, hematology, urinalysis, clinical chemistry parameters, or macro- or microscopic changes in any organs. The satellite group did not show any adverse effect after 14-day recovery period. Thus, the No-Observed-Adverse-Effect-Level (NOAEL) of TCWE was determined to be 1000 mg/kg/day.</p><p><bold>Discussion:</bold> In conclusion, this study established the non-clinical safety of the aqueous extract of <italic>T. cordifolia</italic> stem, which confirms the age-old safe medicinal use of this herb, and also paves the path for future clinical research on formulations containing <italic>Tinospora cordifolia</italic>.</p>