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Toxicol Rep. 2018 Apr 7;5:497-503. doi: 10.1016/j.toxrep.2018.04.001. eCollection 2018.

Oral toxicity study of sports nutritional powder in Wistar rats: A 90 day repeated dose study.

Author information

1
R&D Centre, Aurea Biolabs (P) Ltd, Kolenchery, Cochin, Kerala, India.
2
Bio-Agile Therapeutics Private Limited, Niran Arcade, 563/564, Ground floor, New Bel Road, Bengaluru, Karnataka, India.
3
Department of Pharmacology, Acharya & B.M. Reddy College of Pharmacy, Bengaluru, Karnataka, India.

Abstract

Fitnox is a newly developed dietary ingredient for physical endurance composed of the extracts of Moinga oleifera leaf (45-50%), Kaempferia parviflora (black ginger) root (15-20%) and Punica granatum peel (25-30%). The aim of this study was to assess the subchronic oral toxicity of Fitnox (test substance) - in Wistar albino rats. Forty rats equally divided into 4 groups (control male, control female, treatment male and treatment female) administrated the test substance at 1000 mg/kg per rat daily for 90 days. All the animals were observed for body weight, mortality and clinical observations during the entire study. Results revealed no significant changes between the control and Fitnox treated groups. Based on the results, it was concluded that orally administered Fitnox to rats (dose of 1000 mg/kg per rat, orally-90 days) is safe with no drug-related toxicity was observed during the study period. Thus, the no-observed adverse effect level (NOAEL) for the present study is evaluated to be 1000 mg/kg body weight in both the sexes.

KEYWORDS:

Black ginger; Fitnox; Moringa leaf; Oral toxicity; Pomegranate peel; Sports nutritional powder

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