Sub-acute toxicity of justicia betonica l. in wistar albino rats.

Abstract

Introduction: Herbal extracts, such as J. betonica, are increasingly being used in therapeutic settings, necessitating comprehensive scientific investigations into their safety profiles. Aim: This study is designed to assess the sub-acute toxicity of J. betonica extract, specifically in Wistar albino rats, with the aim of understanding its safety parameters and implications for effective therapeutic usage. Method: Nine male Wistar albino rats, aged 10 weeks and each weighing 100g, were used. Following a 7-day acclimatization period, the rats were divided into control (n=3) and treatment groups (n=6). The control group was administered distilled water. Treatment rats were divided into two sub-groups (n=3 each), receiving either a low dose (250 mg/kg) or a medium dose (500 mg/kg) of J. betonica extract orally for a 28-day period. Histopathological evaluations of kidney and liver tissues, along with clinical chemistry tests like ALT, AST, and BUN levels, were conducted. The study adheres to modified OECD (1998) guidelines for sub-acute toxicity evaluation. Results: Findings indicated no significant toxicity effects on liver function, as determined by stable ALT and AST levels. Kidney function showed subtle changes indicated by a significant increase in blood urea nitrogen (BUN) levels at 250 mg/kg and above, but no changes in serum creatinine or histological damage were observed. Conclusion: J. betonica extract appears safe for liver function even at doses up to 500 mg/kg but may induce subtle kidney effects, specifically elevated BUN levels. Further studies are recommended to explore lower dose ranges for establishing the No Observable Adverse Effect Level (NOAEL).