Prediabetes, typically defined as blood glucose levels above normal but below diabetes thresholds, is a risk state that defines a high chance of developing diabetes. Diagnostic criteria for prediabetes have changed over time and currently vary depending on the institution. According to the World Health Organization (WHO), high risk for developing diabetes relates to two distinct states, impaired fasting glucose (IFG) defined as fasting plasma glucose (FPG) of 6.1–6.9 mmol/L (in the absence of impaired glucose tolerance – IGT) and IGT defined as postload plasma glucose of 7.8–11.0 mmol/L based on 2-h oral glucose tolerance test (OGTT) or a combination of both. The American Diabetes Association (ADA), although applying the same thresholds for IGT, uses a lower cut-off value for IFG (FPG 5.6–6.9 mmol/L) and has additionally introduced HbA1c levels of 5.7–6.4% as a new category of high diabetes risk.

Prediabetes, also known as intermediate hyperglycemia, is a high-risk state for diabetes. About 5–10% of people per year with prediabetes will progress to diabetes, with the same proportion converting back to normoglycemia. The worldwide prevalence of prediabetes is increasing and experts have projected that more than 470 million people will have prediabetes by the year 2030. Prediabetes is associated with the simultaneous presence of insulin resistance and β-cell dysfunction—abnormalities that start before glucose changes are detectable. Those individuals suffering from pre-diabetes may often suffer from hyperlipidaemia, hypertension and insulin resistance linked obesity obesity—all factors that sharply increase the risk of heart disease. Observational evidence shows associations of pre-diabetes with early forms of nephropathy, chronic kidney disease, small fibre neuropathy, diabetic retinopathy, and increased risk of macrovascular disease.

Multifactorial risk scores could optimize the estimation of diabetes risk using non-invasive parameters and blood-based metabolic traits in addition to glycaemic. One of such score is Indian Diabetes Risk Score (IDRS). IDRS score was developed using four simple parameters namely age, abdominal obesity, family history of diabetes and physical activity. It is highly cost effective way of testing prediabetes in a resource poor setting like India. Higher IDRS is associated with higher risk of prediabetes, metabolic syndrome, CVD risk, etc.

Pre-diabetes is one of the major clinically entity, which have been vividly described in Ayurvedic classics in the context of Prameha striking resemblance with the available latest knowledge in this field. Lifestyle and dietary errors are the major etiological categories described for Prameha, which is closely resemblance with the etiology of Pre-diabetes. If left uncontrolled for a prolonged duration, it may lead to Madhumeha or Diabetes mellitus. 

The indigenous compound drug Nisha-amalaki selected for study is a combination of Haridra (Curcuma longa) and Amalaki (Emblica officinalis) as advocated by Vagbhata as a drug of choice for the treatment of Prameha. Based on the above hypothesis the present study has been undertaken to evaluate the efficacy of Nisha-amalaki capsules in patients with Pre-diabetes. Hence in the present study, we will be studying the efficacy, safety and tolerability of Nisha-Amalaki when given in an encapsulated dosage form to patients diagnosed with Pre-diabetes.