Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes

Inclusion criteria

• Adult males and non-pregnant females aged ≥30 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) and a diabetes and a meeting one of the following criteria

• Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
• 2-h Post load Glucose ≥140 mg/dL during an Oral Glucose Tolerance Test (OGTT). The test should be performed as described by the World Health Organisation(WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR
• Glycosylated haemoglobin (A1C) ≥5.7%. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized. OR
• In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose ≥200 mg/dL in the last 12 months.

Exclusion criteria

• Any one of the following

• History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
• Any history suggestive of micro vascular or macro vascular disease
• Women in childbearing age unable to practice any form of contraception
• Impaired renal function; estimated glomerular filtration rate(eGFR) <60mls/min/1.73m2.
• Known history of any chronic illness taking regular pharmacological agents.
• Blood pressure fluctuations exceeding 10 mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 2 or more antihypertensive medications regularly in the last 6 weeks
• Current or former employees of organic India
• Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
• Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.