A study to evaluate the effectiveness and safety of Aloe vera gel powder in adults with prediabetes

INTERVENTION: Intervention1: Treatment Group 1: 100 mg Aloe barbadensis Gel Powder extract: twice a day 15 min before meal for 90 days. Intervention2: Treatment Group 2: 150 mg Aloe barbadensis Gel Powder extract: once a day 15 min before meal for 90 days. Control Intervention1: NIL: NIL Control Intervention2: NIL: NIL CONDITION: Health Condition 1: R739‐ Hyperglycemia, unspecified PRIMARY OUTCOME: Assessing improvement in glycemic control, insulin resistance, and overall metabolic health. This includes evaluation of glycemic parameters‐HbA1c, fasting and post‐meal plasma glucose, insulin resistance markers‐fasting insulin and HOMA‐IR, serum adiponectin, Metabolic Syndrome Severity Z‐score, anthropometric parameters‐body weight, BMI, waist circumference, quality of life score.Timepoint: from screening to day 90. SECONDARY OUTCOME: 1. Adverse events profileTimepoint: 1. from baseline to end of the ; study. 2. Tolerability and compliance of the investigational productTimepoint: 2. from baseline to end of the study. 3. Changes in biochemical parameters like liver function test, renal ; function test and haematological profileTimepoint: 3. at screening and end of the study. 4. Changes in vital signs like blood pressure, heart rate etcTimepoint: 4. on screening, baseline, day 60, day 90. INCLUSION CRITERIA: 1. Male and females aged 20‐60 years, both inclusive 2. Participants with BMI greater than or equal to 25.00 and less than or equal to 34.9 kg/m2 at screening, Overweight to obese class I 3. Participants with Hemoglobin A1c greater than or equal to 5.7 percent and less than or equal to 6.4 percent 4. Participants with Fasting Plasma Glucose between 100‐125 mg/dl, both inclusive, 2 hours glucose value between 140‐199 mg/dl, both inclusive 5. Participants providing voluntary, written informed consent to participate in the study.