Prospective Randomized Clinical Study to Evaluate the Effect of DiabetEaze Powder in Nutritional Management of Pre-Diabetes & Type 2 Diabetes Mellitus

This is Prospective Randomized Clinical Study to Evaluate the Effect ofDiabetEaze Powder in Nutritional Management of Pre-Diabetes & Type 2Diabetes Mellitus. DiabetEaze Powder is a poly herbal nutraceuticalsupplement manufactured in GMP certified factory of PankajakasthuriHerbals India Pvt. Ltd, Thiruvananthapuram, Kerala, India. In addition toNutritional Management, we further aimed to study the complicationsreduction and quality of life improvement in Type 2 Diabetes Mellitus. Atinclusion, subjects who meet all inclusion criteria and no exclusion criteriawill be assigned for the trial to receive an oral dose of 10 g/day [5g twicedaily] along with milk or water. Once the subject is randomized theSponsor Representative or the Study Investigator will provide the studystaff with a unique randomization number for the subject. The initial assessment will bedone before the commencement of the study (0th day) and simultaneouslythe study will be initiated. Further assessment will be done on the 3rdmonth and will be followed on every six months till the completion of thestudy (i.e. 90th, 180th, 365th, 545th& 730th day). Interim data analysis will bedone at the end of first six months (180th day) and report will be published.