Sub-acute toxicity of the standardised extract of Boesenbergia rotunda in rats

Abstract

An in vitro study of Thai medicinal plants revealed anti-SARS-CoV-2 activity of ethanolic extract of Boesenbergia rotunda and its bioactive component of panduratin A. The present study aims to evaluate the safety of the extract after 28 consecutive days of oral doses according to OECD GLP 407. The 28-day repeated oral doses were performed in both male and female Wistar rats. Three doses of 150, 300 and 600 mg/kg/day were assigned as low, medium and high doses, respectively. During the 28-day administration period, there was no evidence of morbidity, mortality, or neurological toxicity for both gender in all doses. Weight and food and water intake in all doses were similar to the control group. The hematological and clinical biochemistry parameters were within normal ranges of Wistar rats. The oestrous cycle of female animals of all groups was normal and the vaginal cytology investigation showed no abnormal cellular types. The statistically significant difference of the weight of organs showed no-test item-related effects and histopathological examination revealed no remarkable lesion. The no observed adverse effect level (NOAEL) of the ethanolic extract of B. rotunda after 28 consecutive days was considered to be 600 mg/kg body weight per day. These findings are useful information for developing B. rotunda extract as a potential phytopharmaceutical product for future clinical investigation.