Study of pharmacodynamic interaction of Phyllanthus emblica extract with clopidogrel and ecosprin in patients with type II diabetes mellitus

Abstract

BackgroundDiabetes mellitus is associated with oxidative stress which impairs the platelet function. Phyllanthus emblica extract a rich source of vitamin C plays an important role in scavenging free radicals. The effect of vitamin C on platelet aggregation in healthy and coronary artery disease patients has been demonstrated. The present study attempts to study the pharmacodynamic interactions of P. emblica extract with clopidogrel and ecosprin. Materials and methodsThis was a randomized open label crossover study of 10 type II diabetic patients. The dosage schedules were either single dose of 500mg P. emblica extract or 75mg clopidogrel or 75mg ecosprin or 500mg P. emblica+75mg clopidogrel or 500mg P. emblica+75mg ecosprin. After single dose study and washout period, patients received either 500mg P. emblica extract twice daily or 75mg clopidogrel or 75mg ecosprin once daily or combinations for 10 days. Platelet aggregation was measured at baseline and at 4h of treatment after single and multiple dose study along with recording of bleeding and clotting time. ResultsAfter single and multiple dose administration of the three treatments and with combinations there was statistically significant decrease of platelet aggregation compared to baseline. Further, the mean percent inhibition of platelet aggregation was significant, when compared between single and multiple doses of P. emblica. The bleeding and clotting time was prolonged with single and multiple dose administration of all treatments compared to baseline. All treatments were well tolerated. ConclusionP. emblica extract demonstrated significant antiplatelet activity with both single and multiple dose administration.