A 90-day Repeated Oral Dose Toxicity Study of Mixed Extract of Fenugreek Seeds and Lespedeza Cuneata in Rats

Abstract

This study was aimed at assessing the safety of a mixed extract of fenugreek seeds and Lespedeza cuneata (YHM), which effectively relieves male menopausal symptoms. To this end, male and female Sprague-Dawley rats were divided into the following groups and repeatedly administered YHM 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; and urinalysis, blood chemistry and biochemistry tests, and histopathological tests were performed to assess the toxicity of YHM. The no-observed-adverse-effect level of YHM was 2,000 mg/kg/day for all male and female rats. While in the YHM-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, on the basis of our findings, we consider that YHM may be a safe, non-toxic substance for alleviating male menopausal symptoms.