Safety assessment of the standardized extract of Carissa edulis root bark in rats.

ETHNOPHARMACOLOGICAL RELEVANCE: Preparations of Carissa edulis (Vahl) have been used in the Nigerian traditional medicine for the management of fever, sickle cell disease, epilepsy, pain and inflammation for many years and their efficacy is widely acclaimed among the Hausa communities of northern Nigeria.

AIM OF THE STUDY: The present studies aimed at evaluating the toxicological properties of the standardized ethanol extract of C. edulis root bark in rats, in order to determine its safety and to complement earlier efficacy studies on this widely used medicinal plant.

MATERIALS AND METHODS: High performance liquid chromatography (HPLC) and preliminary phytochemical analysis of the extract were conducted and its oral median lethal dose (LD50) determined. Signs of toxicity, body weight changes, relative organs weight, feed and water consumption were monitored following 28 days of daily oral administration of graded doses of the extract in rats. Effects of the extract on sex hormones, low- and high-density lipids, hematological and biochemical parameters were examined and pathological changes of the vital organs after treatment with the extract were also investigated.

RESULTS: The oral LD50 of the extract was estimated to be >5000 mg/kg. The body weights of treated rats increased progressively, but the changes were not significantly different from the control groups. The extract neither produces significant changes in feed and water consumption nor affected the relative organs weight. Although some variations were observed in hormonal and lipid profiles hematological and biochemical indices, these important parameters were normal and within acceptable limits. No lesions or pathological changes of the organs attributable to treatment with the extract were observed from the pathological examinations. The HPLC fingerprint of the extract shows a spectrum profile characteristic of C. edulis, while the preliminary phytochemical screening revealed the presence of saponins, flavonoids, tannins, anthraquinones and cardiac glycosides.

CONCLUSION: Our results provided evidence that short-term administration of the standardized ethanol extract of C. edulis root bark at doses lower than 1000 mg/kg is safe in rats and may not exert severe toxic effects.