Preclinical safety and efficacy evaluation of combined Indigofera spicata Forssk and Indigofera trita Linn.f extract in abnormal uterine bleeding using albino rats

Abstract

Background: This study aimed at justifying folk use of a combination of the plants Indigofera Spicata Forssk and Indigofera Trita Linn.f in the treatment of abnormal uterine bleeding. Objectives: The overall objective was to determine if the fresh aqueous aerial extract of combined Indigofera Spicata Forssk and Indigofera Trita Linn.f is safe and efficacious in the treatment of abnormal uterine bleeding using albino rats and present a potential formulation for use in the clinical trials. Methods: Experimental methods were used which involved acute and sub-chronic toxicity testing as well as efficacy testing that involved in vivo anti-inflammatory and ex vivo anti-fibrinolytic activities. Computerized simple randomization was used to allocate female albino rats aged between 5-6 weeks weighing ±20% of the mean weight into groups. A capsule dosage form was selected for formulation in which granulated fresh aerial parts of the herbs were filled after extraction by cold aqueous maceration and fan drying at room temperature. Mean ± SEM, Percentages (%) and one way analysis of variance (ANOVA) were used for statistical evaluation with p<0.05 considered significant. Findings: The safe therapeutic dose was found to be 300mg/kg containing 200mg/kg of Spicata and 100mg/kg of Trita. Conclusion: Folk practice is justified at a dose of 300mg/kg of dried extract consisting of 200mg/kg of Spicata and 100mg/kg of Trita equivalent to 180 ml approximately ¼ cup of crude drug.