A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines on the glycemic control in prediabetic adults

Prediabetes is an intermediate state of hyperglycemia characterized by elevated blood glucose with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and/or increased glycated hemoglobin (HbA1c) percentage. The ADA diagnoses prediabetes with an FBS of 100-125 mg/dl, an OGTT of 140-199 mg/dl, and/or an HbA1c value of 5.7-6.4%. Prediabetic individuals are at higher risk of developing T2DM, cardiovascular disease, stroke, microvascular, and macrovascular complications compared to normoglycemic individuals. Prediabetes in adults often leads to increased blood sugar levels without any symptoms, requiring proper screening and monitoring. Symptoms may include increased appetite, weight loss, raised BMI, fatigue, vision issues, and dermatological infections. Lifestyle modifications and metformin are the mainstream therapies for preventing T2DM in individuals with prediabetes. But they temporarily lower blood sugar levels but do not alter disease progression. 20-30% of patients may experience some adverse effects, including nausea, vomiting, diarrhea, bloating, and abdominal pain. [4] Previously, few clinical trials have been done in homeopathy, most of which have shown promising results in lowering blood glycemic parameters through homeopathic intervention in the treatment of prediabetes. Previous randomized, placebo-controlled trials are conducted at a 1:1 ratio. However, further studies are needed to confirm the efficacy of IHMs in prediabetic adults by replicating the existing trials with a larger sample size. This trial is merely another attempt to detect and prove the efficacy of IHMs in reducing blood glycemic parameters by a 2:1 randomized ratio in 135 participants with prediabetes at the OPD of D.N. De Homoeopathic Medical College and Hospital. Assessment will be done by estimating the serum HbA1c% (primary), FBS, OGTT, lipid profile, liver enzymes (ALT and AST), SF-12, and MYMOP2 questionnaires (secondary), which will be measured monthly for up to 3 months. A comparative analysis will be conducted to detect group differences.