A Single-blind, Randomized, Controlled, Phase IV, Proof-of-Concept, comparative study to evaluate the efficacy and safety of Nisha-Amalki capsules in preventing progression to Diabetes in patients with Pre-Diabetes

Prediabetes, typically defined as blood glucose levels abovenormal but below diabetes thresholds, is a risk state that defines a highchance of developing diabetes. Diagnostic criteria for prediabetes have changedover time and currently vary depending on the institution. According to theWorld Health Organization (WHO), high risk for developing diabetes relates totwo distinct states, impaired fasting glucose (IFG) defined as fasting plasmaglucose (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-horal glucose tolerance test (OGTT) or a combination of both. TheAmerican Diabetes Association (ADA), although applying the same thresholds forIGT, uses a lower cut-off value for IFG (FPG 5.6–6.9 mmol/L) and hasadditionally introduced HbA1c levels of 5.7–6.4% as a new category of highdiabetes risk.

Prediabetes, also known as intermediate hyperglycemia, is ahigh-risk state for diabetes. About 5–10% of people per year with prediabeteswill progress to diabetes, with the same proportion converting back tonormoglycemia. The worldwide prevalence of prediabetes is increasing andexperts have projected that more than 470 million people will have prediabetesby the year 2030. Prediabetes is associated with the simultaneouspresence of insulin resistance and β-cell dysfunction—abnormalities that startbefore glucose changes are detectable. Those individuals suffering frompre-diabetes may often suffer from hyperlipidaemia, hypertension and insulinresistance linked obesity obesity—all factors that sharply increase the risk ofheart disease.Observational evidence shows associations of pre-diabeteswith 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 ofdiabetes risk using non-invasive parameters and blood-based metabolic traits inaddition to glycaemic. One of such score is Indian Diabetes Risk Score (IDRS).IDRS score was developed using four simple parameters namely age, abdominalobesity, family history of diabetes and physical activity. It is highly costeffective 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, whichhave been vividly described in Ayurvedic classics in the context of Pramehastriking resemblance with the available latest knowledge in this field. Lifestyleand dietary errors are the major etiological categories described for Prameha,which is closely resemblance with the etiology of Pre-diabetes. If leftuncontrolled for a prolonged duration, it may lead to Madhumeha or Diabetesmellitus.

The indigenous compound drug Nisha-amalaki selected forstudy is a combination of Haridra(Curcuma longa) and Amalaki (Emblicaofficinalis) as advocated by Vagbhataas a drug of choice for the treatment of Prameha.Based on the above hypothesis the present study has been undertaken to evaluatethe efficacy of Nisha-amalaki capsulesin patients with Pre-diabetes. Hence in the present study,we will be studying the efficacy, safety and tolerability of Nisha-Amalakiwhen given in an encapsulateddosage form to patients diagnosed withPre-diabetes.