A clinical study to assess the effect of a herbal product named Glysikot granules in patients with Type 2 Diabetes Melitus

INTERVENTION: Intervention1: Glysikot granule 5g oral dose tid for 6 months: Each 5 g granule contains, Amrita (Tinospora cordifolia) 0.416 g Abhaya(Terminalia chebula) 0.416 g Dhatri(Phyllanthus emblica) 0.833 g Ratri(Curcuma longa) 0.833 g Meharimula(Salacia reticulate) 2.500 g Control Intervention1: Metformin and Glysikot granule 5g oral dose tid for 6 months: This was given to subjects in Group B who were on a stable dose of metformin alone and were having insufficient glucose control CONDITION: Type 2 Diabetes Melitus PRIMARY OUTCOME: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 24 (End of study). HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent‐‐‐‐‐‐Timepoint: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 24 (End of study). HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent SECONDARY OUTCOME: â?¢Change from Baseline in Fasting Plasma Glucose (FPG) to Week 24 ; â?¢Change from Baseline in 2‐hr Post‐Meal Glucose (PMG) to Week 24 ; â?¢Changes from Baseline in Lipid Profile to Week 24 ; â?¢Changes from Baseline in BMI to Week 24 ; â?¢Symptomatic changes assessed using Ayurvedic symptom questionnaire from Baseline to week 24 to assess changes in quality of life. ; ‐‐‐‐‐‐Timepoint: Week 0 to Week 24 INCLUSION CRITERIA: 1.Patients between 30‐60 age, both sex. 2.Body mass index (BMI) below 40 kg/m². Group A. 1.Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment. 2.Hemoglobin A1c (HbA1c) â?¥7.5% and â?¤11% 3.Fasting Plasma Glucose (FPG) â?¥130 mg/dL Group B. 1.25 patients with Type 2 DM with Metformin alone having insufficient glucose control. 2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) â?¥7.5% and â?¤11% and a Fasting Plasma Glucose (FPG) â?¥130 mg/dL