Effect of aqueous/methanolic extract of Ocimum sanctum (OciBest) on the Male and Female reproductive performance of wistar rats

Background: Ocimum sanctum (OSE) has been used in the Indian system of traditional medicine (Ayurveda) for the treatment and prevention of various diseases. However, the contradictory reports regarding the reproductive safety of OSE prompted us to re-verify its effect on the reproductive system by following internationally accepted Organization for Economic Cooperation and Development guideline 415. Objective: To study the effect of aqueous/methanolic extract of OSE (OciBest) on the male and female reproductive performance of Wistar rats. Materials and Methods: Rats were orally gavaged with OciBest at dose levels of 0, 250, 500, and 1000 mg/kg. Males were administered with OciBest for 12 weeks before and during the mating period. On the other hand, females received OciBest for 2 weeks before mating until the end of the lactation period. Results: OciBest at 1000 mg/kg did not induce any adverse effects on the reproductive performance of male and female rats. All the treated parent animals survived until the end of the study period with no major signs of clinical toxicity. The body weights, food consumption, male and female fertility indices, organ weights, as well as gross pathological and histopathology observations in parent animals, did not reveal any treatment-related adverse effects. Moreover, in comparison to the control groups, OciBest did not induce any treatment-related adverse effects to the offsprings. Conclusion: Thus, no-observed adverse effect level was found up to 1000 mg/kg dose, suggesting the safety of OciBest for reproductive system.