Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation

This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.

volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.

On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.

Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.

Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.

Inclusion criteria

• Age: 18-59
• Impaired Fasting Glucose (100-125mg/dl)
• Impaired Glucose Tolerance (140-199mg/dl) 2h-75gm OGTT
• History of Diabetes in first degree relation with one condition
• At high risk with BMI > 35%
• Early onset diabetic / accidental on screening (glucose >200mg/dl)

Exclusion criteria

• on renal dialysis;
• an acute or terminal illness or serious mental illness;
• history of recent coronary event within the last 12 months;
• a recent history of acute medical problem or admission to hospital;
• any other severe medical conditions that need intervention / treatment
• has poor short-term prognosis (expected death in <2 years);
• is planning to travel for longer than 6 weeks during the 6-week intervention period; or
• is with compromised liver / kidney / cardiac function
• older patients of DM taking any form of medication / intervention