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 of
DiabetEaze Powder in Nutritional Management of Pre-Diabetes & Type 2
Diabetes Mellitus. DiabetEaze Powder is a poly herbal nutraceutical
supplement manufactured in GMP certified factory of Pankajakasthuri
Herbals India Pvt. Ltd, Thiruvananthapuram, Kerala, India. In addition to
Nutritional Management, we further aimed to study the complications
reduction and quality of life improvement in Type 2 Diabetes Mellitus. At
inclusion, subjects who meet all inclusion criteria and no exclusion criteria
will be assigned for the trial to receive an oral dose of 10 g/day [5g twice
daily] along with milk or water. Once the subject is randomized the
Sponsor Representative or the Study Investigator will provide the study
staff with a unique randomization number for the subject. The initial assessment will be
done before the commencement of the study (0th day) and simultaneously
the study will be initiated. Further assessment will be done on the 3rd
month and will be followed on every six months till the completion of the
study (i.e. 90th, 180th, 365th, 545th& 730th day). Interim data analysis will be
done at the end of first six months (180th day) and report will be published.