90-Day Repeated-Dose Toxicological Assessment of MUVZ in Sprague Dawley Rats: Subchronic Study.

Abstract

Objectives: Vitex negundo and Zingiber officinale are predominantly used in day-to-day life as food or supplements. Both are being reported individually for therapeutic properties. A food supplement consisting of leaves and twigs of Vitex negundo and rhizome of Zingiber officinale, the first-of-a-kind proprietary blend extract (MUVZ), was developed for joint health.

Methods: As part of the safety profile, a subchronic toxicity study was performed in Sprague Dawley rats under compliance with Good Laboratory Practice (GLP). The study aimed to determine the potential toxicity of MUVZ following oral (gavage) administration by following Organisation for Economic Co-operation and Development (OECD) Guideline 408. MUVZ was administered for 90 days, with a recovery period of 28 days. MUVZ was administered at 0 (G1), 1000 (G2), 2000 (G3) and 3000 (G4) mg.kg^-1 body weight (n = 10/sex/group); vehicle control (G1R) and high-dose recovery groups 3000 mg.kg^-1·b.w (G4R) (n = 5/sex/group).

Results: No MUVZ-related effects were observed in mortality, morbidity, detailed clinical signs, body weight and feed consumption. Statistical significance was found in levels of clinical pathology parameters; however, there was no dose dependency, and further correlative histopathological findings were observed. At the end of the experimental trial, no test article-induced gross and microscopic pathological lesions were observed across the treatment groups.

Conclusions: Based on the findings, no toxicologically significant findings were derived at the highest dose of 3000 mg.kg^-1 body weight.