A Clinical trial to study the effects of a unani formulation 'Diabeat'in patients with high blood sugar levels (Type 2 diabetes mellitus )

INTERVENTION: Intervention1: Diabeat: 2000 mg for 3 months in divided doses Control Intervention1: Placebo: 2000 mg for 3 months in divided doses CONDITION: Type 2 Diabetes mellitus PRIMARY OUTCOME: To achieve a good glycemic control (FPG‐80‐120 mg/dl; PPG‐80‐140 mg/dl)‐‐‐‐‐‐Timepoint: 4,8,and 12 weeks SECONDARY OUTCOME: Mean HbA1C< 6.5%‐‐‐‐‐‐Timepoint: 3months INCLUSION CRITERIA: 1.Subjects with a history of type‐2 diabetes mellitus for < 5 year duration taking only oral antidiabetic agents/not taking any medication. 2.Patients having poor response or no response with diet & exercise alone. 3.Following two groups of subjects will be included in the study: (1) Subjects with impaired fasting glycemia and impaired glucose tolerance i.e. subjects with prediabetes (Fasting Blood Glucose‐100‐120 mg/dl and 75 gm Glucose Tolerance Test values ‐140‐180 mg/dl) (2) Subjects with Fasting Blood Glucose >125 mg/dl and 2‐ hour Oral Glucose Tolerance Test values >180 mg/dl (i.e. subjects with type‐2 diabetes mellitus) 4.Patients of either sex between the ages of 18‐64years. 5.Patients who are able and willing to follow anti‐diabetic therapy under a stable life style with regular diabetic meals 6.Patients who are willing and able to understand and follow the protocol and provide informed consent.