Acute and Sub-Acute Oral Toxicity Assessment of Mixed Extract of Trigonella Foenum-Graecum Seeds and Withania Somnifera Root in Rats

This study aimed at assessing the safety of a mixed extract of Trigonella Foenum-graecum seeds and Withania Somnifera root (TFWS), which effectively relieves male menopausal symptoms. To this end, male and female Sprague-Dawley rats were divided into the following groups and repeatedly administered TFWS orally for 90 days: control, low-dose (500 mg/kg/day), intermediate-dose (1,000 mg/kg/day), and high-dose (2,000 mg/kg/day) groups. The animals were monitored for general symptoms; their body weights and electrolyte levels were measured; urinalysis, blood chemistry, biochemistry tests, and histopathological tests were performed to assess the toxicity of TFWS. The no-observed-adverse-effect level of TFWS was 2,000 mg/kg/day for all male and female rats. While in the TFWS-administered and control groups, most parameters were within the normal range; some rats in the high-dose group showed changes not induced by the test substance but which may be specific to an individual animal or may occur naturally. Thus, based on our findings, we consider that TFWS may be a safe, non-toxic substance for alleviating male menopausal symptoms.