title: Safety evaluation of Phytovagex, a pessary formulation of Nigella sativa, on pregnant rats.
abstract: OBJECTIVE
  The possible toxicity of drugs in pregnancy should be tested before their use in pregnant patients. In the present study, we aimed to evaluate the safety of phytovagex, a pessary formulation of Nigella sativa (N. sativa), which is already in clinical use for vaginal fungal infection.
  
  
  METHODS
  The pregnant rats were treated intravaginal with physiological saline (vehicle) or phytovagex pessary in the first half of their pregnancy (days 1 to 10 of gestation). Duration of pregnancy and health parameters of the newborns were recorded after parturition. Also, cytotoxicity of N. sativa hydroalcoholic extract was tested against ovary Cho cells.
  
  
  RESULTS
  The phytovagex had no significant effect on the duration of pregnancy, number of newborns, weight of neonates, and percent of stillbirth. No deformity or general behavioral abnormality was observed in neonates monitored for 30 days after birth. N. sativa extract had no significant effect on the viability of ovary cells at the concentrations of 12.5-200 µg/mL.
  
  
  CONCLUSIONS
  Results of this animal study showed that phytovagex has no overall effect on the duration of pregnancy and health parameters of the newborns. Also, its active agent, N. sativa, does not induce any cytotoxic effect on ovary cells.
authors.affiliation: Department of Medical Biotechnology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Reza
authors.initials: R
authors.lastname: Salarinia
authors.affiliation: Pharmacological Research Center of Medicinal Plants, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Pharmacology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Hassan
authors.initials: H
authors.lastname: Rakhshandeh
authors.affiliation: Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Davood
authors.initials: D
authors.lastname: Oliaee
authors.affiliation: Neurogenic Inflammation Research Centre, Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Sima
authors.initials: S
authors.lastname: Gul Ghasemi
authors.affiliation: Pharmacological Research Center of Medicinal Plants, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Ghorbani
keywords: Nigella sativa; Pregnancy; Rat; Stillbirth