Tinospora cordifolia‐associated hepatotoxicity has been scientifically misconstrued, in haste

Balkrishna, Acharya; Bhattacharya, Kunal; Sinha, Sandeep; Srivastava, Jyotish; Haldar, Swati; Varshney, Anurag

doi:10.1002/hep4.2050

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“…However, few recent studies have reported apparent hepatotoxicity in clinical subjects who consumed T. cordifolia ( Nagral et al, 2021 ; Kulkarni et al, 2022 ). These reports associating hepatotoxicity with T. cordifolia have been rebutted through critical discussions in letters to the editors ( Balkrishna et al, 2022a ; Bakrishna et al, 2022 ). Nevertheless, scientifically it is of utmost pertinence that non-clinical safety of T. cordifolia is evaluated following good laboratory practice (GLP) as per OECD guidelines for toxicological validation of drugs, much like what has been done for Withania somnifera ( Balkrishna et al, 2022b ).…”

Section: Discussionmentioning

confidence: 99%

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

2023

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Introduction:Tinospora cordifolia (Wild.) Hook.f. & Thomson (Giloy), has been widely used in the Ayurvedic system of medicine. However, some sporadic under-powered case studies have recently reported Tinospora cordifolia associated toxicity. Thus, following OECD 407 guidelines, a 28-day-repeated-dose-14-day-recovery toxicological evaluation of the aqueous extract of T. cordifolia stem (TCWE) was conducted under good laboratory practice (GLP), in Sprague-Dawley (SD) rats.Methods: 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.Results: 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.Discussion: In conclusion, this study established the non-clinical safety of the aqueous extract of T. cordifolia stem, which confirms the age-old safe medicinal use of this herb, and also paves the path for future clinical research on formulations containing Tinospora cordifolia.

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