A Double Blinded Randomized Placebo Controlled Trial Evaluating the Efficacy of Riboflavin and its Association with MTHFR Gene Polymorphism in Treatment Naive Patients of Diabetic Neuropathy

This study is a double blinded randomized placebo controlled clinical trial designed to evaluate the efficacy of riboflavin Vitamin B2 in treatment naive patients with painful diabetic neuropathy and to explore the influence of MTHFR C677T gene polymorphism on treatment response. A total of 80 patients will be enrolled and randomized into two groups one receiving 100 mg oral riboflavin daily and the other receiving placebo for a duration of three months. The study will assess changes in neuropathic symptoms using the Michigan Neuropathy Screening Instrument MNSI nerve conduction studies NCV quality of life scores Norfolk QOL DN and monitor adverse effects. Genetic testing for MTHFR polymorphism will be conducted at baseline using PCR based sequencing. Statistical analysis will include intergroup comparisons and multivariate regression to evaluate the association between genetic variants and clinical outcomes. The aim is to determine whether riboflavin can serve as a safe cost effective therapeutic option in diabetic neuropathy and whether genotype influences treatment efficacy