A clinical trial to study safety and activity of Ayurvedic formulation containing Ashwagandha and Haridra in patients with Type 2 Diabetes mellitus receiving oral anti-diabetic agents

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: Type 2 Diabetes mellitus on oral anti‐diabetic agents 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, less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups, improvement in the signs & symptom score by more than 10% in the group receiving PHP‐Diabetes as compared to placebo at the end of three months treatment and total number of patients showing reduction in the blood sugar levels by more than 3/10 in the group receiving PHP‐Diabetes as compared to placebo at the end of three months treatment.‐‐‐‐‐‐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 with type 2 diabetes mellitus (with duration of diabetes at least 2 years) on sulfonylurea (SU) (half of the maximum prescribed dose) and/or Metformin (1500mg/day) for at least one month prior to enrolling the patient in the study 3. Patients with fasting blood glucose more than 126mg % and /or with post‐prandial blood glucose (after a standard meal) more than 162mg. %. 4. Patients with HbA1c between 7.0‐9.5 %. 5. Patients ready to abide by trial procedures and to give informed consent.