Toxicological Evaluation of Double Root Coffee®- a polyherbal formulation in Male Adult Wistar Rats

Double Root Coffee® is a polyherbal mixture of E.longifolia, L.meyenii, W. somnifera, and Arabica coffee promoted as an aphrodisiac. Despite its usage, there is no evidence validating the claims and their toxicological effects. This study set out to validate the use and the sub-chronic toxicity effect of the Double Root Coffee®. Double root coffee® was purchased from Anambra state, and phytochemical analysis and the oral acute toxicity (LD50) were determined. The dosages of 1/20th, 1/10th, and 1/5th of the LD50 were selected for further investigation. The sub-chronic toxicity effect of the mixture was evaluated using forty (40) adult rats divided into four groups (n =10): normal control (10ml/kg), groups 2, 3 and 4 received 250 mg/kg, 500 mg/kg and 1000 mg/kg, and treated orally for 60 days. On the 61st day, the blood was collected for hematological and biochemical analysis. Antioxidant activities of catalase (CAT), superoxide dismutase (SOD) and malondialdehyde (MDA) were also determined using their standard methods. Epididymal sperm quality and testosterone hormone assays were also evaluated. The liver,  kidney, heart, spleen and testes were   excised for histopathological examination. The phytochemicals present include alkaloids, saponins, tannins and carbohydrates. The LD50 was found to be above 5000 mg/kg. Sub-chronic administration of double root coffee® caused anon-significant change (p>0.05) in serum levels of ALT, AST, ALP, creatinine, urea, uric acid, SOD, CAT and MDA, and non- significant changes in hematological indices (PCV, RBC, WBC, Hb, MCV, MCH, and MCHC). The double root coffee® caused a non-significant decrease in sperm quality and morphology, and testosterone hormone. Histopathological analysis revealed preserved organ architecture. Double Root Coffee® appears non-toxic under both acute and 60-day repeated-dose treatment, and invalidates the aphrodisiac properties of the mixture.