TY - JOUR ID - 6230 TI - Safety evaluation of Phytovagex, a pessary formulation of Nigella sativa, on pregnant rats JO - Avicenna Journal of Phytomedicine JA - AJP LA - en SN - 2228-7930 AU - Salarinia, Reza AU - Rakhshandeh, Hassan AU - Oliaee, Davood AU - Sima Gul Ghasemi, Sima Gul AU - Ghorbani, Ahmad AD - Department of Medical Biotechnology, Faculty of Medicine, Mashhad University of Medical Sciences AD - Pharmacological Research Center of Medicinal Plants, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran AD - Student Research Committee, Mashhad University of Medical Sciences AD - Neurogenic Inflammation Research Centre, Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran Y1 - 2016 PY - 2016 VL - 6 IS - 1 SP - 117 EP - 123 KW - Nigella Sativa KW - pregnancy KW - Rat KW - Stillbirth DO - 10.22038/ajp.2016.6230 N2 - 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. Materials and 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. Conclusion: 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. UR - https://ajp.mums.ac.ir/article_6230.html L1 - https://ajp.mums.ac.ir/article_6230_6da359bbad5f36be011359e383f739ce.pdf ER -