A clinical trial to study activity and safety of Ayurvedic formulation containing Ashwagadha and Haridra in patients freshly diagnosed with Type 2 Diabetes mellitus

INTERVENTION: Intervention1: Tablet PHP‐Diabetes containing hydro‐alcoholic extracts of Withania somnifera 150mg and Curcuma longa 250 mg: 500 mg BD for 6 months Control Intervention1: Tablet Placebo: 500 mg BD for 6 months CONDITION: Freshly diagnosed Type 2 Diabetes mellitus PRIMARY OUTCOME: The primary outcome measures will be reduction in HbA1c levels by 0.5% as compared to basal values, reduction in blood sugar (fasting and/or post‐prandial) and lipid levels by more than 25% in the group receiving PHP‐Diabetes as compared to placebo at the end of three months treatment, improvement in the signs & symptoms score by more than 10% in the group receiving PHP‐Diabetes as compared to placebo at the end of three months treatment and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.‐‐‐‐‐‐Timepoint: SECONDARY OUTCOME: The secondary outcome will be improvement in insulin sensitivity as determined by indices of Insulin sensitivity.‐‐‐‐‐‐Timepoint: INCLUSION CRITERIA: Patients satisfying all the following criteria are included in the study: 1. Patients of either sex between the age group 18 to 60 years (both inclusive). 2. Patients who are freshly diagnosed as suffering from Type 2 Diabetes mellitus not on any oral hypoglycemic agent. 3. Patients with HbA1c between 7.0‐9.5 %. 4. Patients ready to abide by trial procedures and to give informed consent.