Effect of Ciklavit® - (A Poly-Herbal Formulation) on the Pharmacokinetics of Proguanil in Healthy Nigerian Volunteers

Abstract

The therapeutic efficacy of herbal medicines in the treatment of human diseases or disorders has gained more attention over the years. A survey established that approximately 15 % of patients receiving orthodox medicine also take herbal products, and among these, potential adverse herbto-drug interactions were observed in 40 % of patients. Recently, there have been reports of herbdrug interactions which have impacted on wellness of users resulting in toxicity or loss of therapeutic efficacy of either the herb or the orthodox drug when co-administered. These reports make herb-drug interactions a research area of public interest. This study was embarked upon to evaluate the effect of Ciklavit® used for the management of sickle cell anaemia on the pharmacokinetic profile of proguanil tablets in healthy Nigerian volunteers. Twelve healthy participants were recruited and completed the study after signing a consent form. The study was performed using a single dose, two-way randomized crossover design. The participants were randomly grouped into control and treatment. The treatment group were administered proguanil tablets with Ciklavit® while the control group took proguanil with water only. The blood and urine samples collected at different time interval for 24 hours were analyzed using HighPerformance Liquid Chromatography. The results obtained, demonstrated that co-administration of Ciklavit® with proguanil altered pharmacokinetic parameters of proguanil but the difference in values were found to be statistically insignificant (p>0.05). The study demonstrated that there are no significant pharmacokinetic interactions between proguanil and Ciklavit® hence the two medicinal agents can be co-administered.&nbsp