Abstract
BACKGROUND: It is essential to generate the reproduction toxicity data of any drug that will be used in pregnancy or during the reproductive phase of life. Ayush AG, a compound herbo-mineral Ayurvedic formulation that is developed for promoting the health of the fetus and mother, was tested to assess its reproductive toxicity profile as per the standard guidelines. MATERIALS AND METHOD: In the fertility toxicity study, Ayush AG, the test drug was administered in three graded doses to Wistar rats (40 male and 40 female) during the premating, mating period, gestation, and lactation periods. Parameters such as estrous cycle, body weight, feed consumption, hematology, serum biochemistry, pup body weight, hematology and biochemistry, histopathology of reproductive organs and reproductive indices were studied. In the embryo-fetal developmental toxicity study, the test drug was administered from day 7 to day 9 of the gestation period in 18 pregnant rats and sacrificed on gestation day 20. Parameters such as body weight during gestation, uterus weight, fetus and placenta weight, gross examination of fetuses for sex, external and visceral anomalies were studied. RESULTS: In the fertility toxicity study, no adverse effect on mating behaviour, estrus cycle, conception rate, body weight, hematological and biochemical parameters, pup growth, or histopathology was found at dose level of 750 mg/kg of Ayush AG. No teratogenic changes were observed in the fetuses in the embryo-fetal developmental toxicity study at dose level of 750 mg/kg. CONCLUSION: Ayush AG, the compound herbo-mineral Ayurvedic formulation, has been demonstrated to be safe at the dose of 750 mg/kg in fertility toxicity and embryo-fetal developmental toxicity studies in Wistar rats.