Prenatal Developmental Toxicity of ARVIDEX® Herbal Medicine in Albino Wistar Rats

Abstract

Background: ARVIDEX® is a polyherbal formulation under experimental development for potential immunomodulatory and antiviral applications. Despite preliminary pharmacological promise, evidence regarding its safety during pregnancy is lacking. This study therefore evaluated the prenatal developmental toxicity of ARVIDEX® in pregnant albino Wistar rats. Methods: Fifty pregnant Wistar rats were randomly allocated to five groups (n=10 per group) and administered ARVIDEX® orally at doses of 250, 500, or 1000 mg/kg, a human equivalent dose (296.7 mg/kg), or distilled water (control) from gestation day 5 to day 19. Maternal endpoints included body weight variation, feed intake, organ weights, and serum biochemical indices. Caesarean section was performed on gestation day 20, followed by assessment of fetal implantation sites, resorption frequency, number of live fetuses, fetal body weight, crown rump length, and external anomalies. Statistical analysis employed one-way analysis of variance (ANOVA) with Dunnett’s or Tukey’s post hoc tests where appropriate. Categorical variables were analyzed using the Chi square or Fisher’s exact test, with statistical significance set at p<0.05. Results: The administration of ARVIDEX® produced dose-related maternal and developmental toxicity. Significant reductions in maternal weight gain and food intake were observed at doses of 500 and 1000 mg/kg (p<0.05). These doses were also associated with increased relative liver and kidney weights, indicating possible hepatorenal stress. Fetal assessments demonstrated significant decreases in implantation sites, litter size, crown rump length, and placental weight at higher dose levels. An increase in resorption rates and a reduction in both male and female fetuses were also recorded compared with controls. Conclusion: The findings indicate that ARVIDEX® induces dose-dependent adverse maternal and developmental effects at moderate to high doses, while no statistically significant adverse effects were observed for the measured maternal and fetal endpoints at the human equivalent dose. These data underscore the need for further safety evaluation and support caution against the use of ARVIDEX® above the recommended doses during pregnancy until additional evidence becomes available.