Background:
Diabetes mellitus is an endocrinological metabolic disorder characterized by elevated blood glucose level due to impaired insulin secretion or cellular insensitivity. Disease is frequent accompanied with disturbed metabolism of carbohydrates, fats and protein, obesity.Poor glycaemic control leads long term macro and micro vascular complications.Diabetics are 30 to 40 times higher at risk of hyperlipoprotinemia and related coronary artery diseases. Surveys say that fasting triglycerides and plasma cholesterols are high in diabetic patients. 
Lifestyle changes, environment factors coupled with genetic factorshas increased incidences of diabetes. The most disturbing trend of disease is shifting in age of onset to10 years younger age. Long term uncontrolled hyperglycemia serve a bridge between diabetes and secondary complications, and so patients diagnosed at younger age are at great risk of diabetic complications.
IDFstates the diabetes has risen from 108 million in 1980 to 422 million in 2015 and by 2040 this will rise to 642 million.India is home to the second largest number of adults living with diabetes. Where 69.18 million people are diabetics, 36.06 million adults are undiagnosed while 1.02 million people are died related to diabetes. In India diabetes related expenditure is almost 4,500 (US $ 120) per person and therefore estimated annual cost 180,000 million rupees, is a huge economic burden for developing India.
Ayurvedic remedies for diabetes are usually combination of multiple herbs with numbers of phytoconstituents with different potential action, which exerts it’s effect by synergistic, potentiative and agonostic action. A developed formula contain various herbs which lowers blood sugar level by different mechanisms coupled with immunomodulatory, detoxicant, antioxidant herbs. A synergistic formula may encounter pathological condition effectively by working on multiple ways and also successfully controls disease arise secondary complications. 


Aim:
The primary objective of our study to evaluate effectiveness of standardise formulation for the initial treatment of diabetes to that of Metformin and assess change in lipid profile.

Method:
A total of 40 newly diagnosed type II diabetic patients were enrolled in non-randomized, open labelled, parallel study design after screening on the basis of medical history and blood sugar level, inclusion and exclusion criteria in diabetic clinic OPD at Parul Sevashram Hospital. Once consented, subjects were tested for Sugar and lipid profile.The group I and II patient were given their respective medication from physician desk. All the investigations height, weight, and waist circumference and parameters fasting blood sugar (FBS), post-prandial blood sugar (PP2BS), hemoglobin A1C, lipid profile were estimated at baseline and end of each month up to 3 months.
Result:
A total of 108 type II diabetic people were screened; from them 46 were enrolled and 66 were excluded. The two parallel arms were treated in a different time frame. In group of formulation, 26 subjects were enrolled from which 6 discontinued study due to some personal reasons and Metformin, 20 subjects were enrolled for intervention.
The mean ages of female and male subjects were 46.9 ±10.1 and 48.6 ±11.2 years respectively in formulation group and 49 ±6.1 and 49 ±8.3 years respectively in metformin group. Formulation showed time dependant significant reduction in FBS and PP2BS, at the end of third month mean % change 32.61± 6.30 % and 40.48 ± 15.30 % were noted in formulation treated group respectively while 18.61 ± 2.25 % and 29.06 ± 6.02 % in metformin treated group. The mean % reduction in glycated haemoglobin was highly significant 13.73% in formulation treated patient to that of Metformin 6.68 %.The % reduction of Total Cholesterol, Total triglyceride, HDL, LDL, VLDL at the end of third month was 42.72 ± 17.80, 37.79 ± 14.32, 8.89 ± 3.37, 31.24 ± 15.35, 50.21 ± 25.23 respectively in formulation group while 11.75 ± 7.56, 16.70 ± 5.79, 1.95 ± 1.2, 16.19 ± 7.32, 17.76 ± 10.06 in metformin group. 
The blood sugar level was controlled within 4–8 weeks depending upon initial blood sugar level. Formulation significantly reduced the glycated haemoglobin levels and significantly modulated the lipid profile. On the basis of the results, it was clearly understood that developed formulation may act through pancreatic and extra pancreatic mechanism(s) and significantly controls blood sugar and lipid level.

Clinical proven standardised and synergistic formula for newly diagnosed type II diabetics