European Journal of Biomedical and Pharmaceutical Sciences

EVALUATION OF TERATOGENIC EFFECTS OF DIFFERENT DOSES OF HERBAL FORMULATION (i-Coffee+) IN WISTAR RAT'S FETUS OR EMBRYO BY NO-OBSERVED-ADVERSE-EFFECT LEVEL (NOAEL) METHOD: AN IN VIVO STUDY

Vadiraj G. Bharadwaj*, Cheppattu Mohammed Abdullah Anzar, Molath Varkey Joseph, Dr. Ramachandran Sundaram and Shariq afsar

ABSTRACT

iCoffee+ is a novel herbal formulation that effectively treats diabetes mellitus; the unique composition has been formulated with herbs, which do not have any teratogenic potential. The purpose of this study was to evaluate the teratogenic potential of the final formulation iCoffee+ on embryos and foetuses as a result of repeated oral administration during pregnancy in Wistar rats by the No-Observed-Adverse-Effect Level (NOAEL) method. Wistar albino rats were used as the experimental animals in four groups, with each group containing twenty pregnant rats. Group I served as a normal control group and received 0.5% CMC vehicle orally, whereas groups II, III, and IV received iCoffee+ at doses of 1.55 g/kg, 3.1 g/kg, and 6.2 g/kg of body weight, respectively. Up to the end of the investigation, all rat groups were evaluated twice daily for mortality, morbidity, and clinical signs and symptoms. Body weight and food consumption were measured twice a week throughout the treatment period, and then lastly on the day of sacrifice. The data was reported as three cumulative values. The fetus was then separated and weighed. The body weight of the fetus was recorded in the raw data. The complete fetuses were checked for skeletal and soft tissue abnormalities. The dams' uteruses were weighed and recorded. The entire before-and-after treatment period did not show any clinical symptoms. With these evidences, we conclude that, consumption of iCoffee+ in large doses of during pregnancy does not possess any health risk.

Keywords: iCoffee+, Wistar rats, Teratogenicity.