A COMPARATIVE STUDY TO EVALUATE THE EFFECT OF HIGHLY STANDARDISED AQUEOUS EXTRACTS OF PHYLLANTHUS EMBLICA, WITHANIA SOMNIFERA AND THEIR COMBINATION ON ENDOTHELIAL DYSFUNCTION AND BIOMARKERS IN PATIENTS WITH TYPE II DIABETES MELLITUSAbstract
Introduction: Biomarkers of oxidative stress and endothelial dysfunction play an important role in the pathogenesis of type II Diabetes Mellitus (DM). The present study was planned to compare the effect of highly standardised aqueous extract of Phyllanthus emblica, Withania somnifera and theircombination on endothelial dysfunction and biomarkers of oxidative stress in patients with type II DM.
Methods: After taking IEC approval and written informed consent, eligible patients were randomized to receive either one of the three treatments, one capsule of Phyllanthus emblica 500 mg twice daily, one capsule of Withania somnifera 500 mg twice daily or one capsule of combination of Phyllanthus emblica 250mg+Withania somnifera 250mg twice daily for a duration of 12 weeks. Efficacy end points were change in endothelial function, change in biomarkers of oxidative stress and systemic inflammation measured at baseline and after 12 weeks of treatment.
Results: Thirty patients completed the study. Twelve weeks treatment with Phyllanthus emblica, Withania somnifera and their combination produced significant reduction in Reflection index (RI) compared to baseline, (-2.17±0.72% Vs -10.09±0.86), (-2.29±0.91% Vs -9.4±1.80%) and (-2.18±1.01% Vs -9.21±1.22%) respectively, suggesting improvement in endothelial function. There was also significant reduction in the biomarkers of oxidative stress and systemic inflammation. All three treatments were well tolerated.
Conclusion: Phyllanthus emblica and Withania somnifera and their combination have shown significant improvement in endothelial function, reduction in biomarkers of oxidative stress and systemic inflammation in patients with type II DM. On further analysis, Phyllanthus emblica has shown a better response compared to other treatment groups.
P. Usharani*, P.V. Kishan, Nishat Fatima and C. Uday Kumar
Department of Clinical Pharmacology & Therapeutics, Nizam’s Institute of Medical Sciences, Hyderabad, Andhra Pradesh, India
30 January, 2014
04 March, 2014
07 June, 2014
01 July, 2014