A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of a Nerve Support Formula on Neuropathic Pain in Individuals Suffering from Type II Diabetes Mellitus

William Cross,1 Shalini Srivastava2 1Research and Development, Vasocorp, Hiram, GA, USA; 2Clinical Development, Vedic Lifesciences, Thane, IndiaCorrespondence: Dr Shalini Srivastava, 118, Morya House, Opp. Infinity Mall, Andheri (West), Mumbai, 400053, Maharashtra, India, Email shalini.s@vediclifesciences.comBackground: The primary objective of the present study was to evaluate the effects of a Nerve Support Formula NeuropAWAY® on diabetic neuropathic pain.Methods: This double-blind, placebo-controlled, randomized trial was conducted between August 2020 and February 2021. Patients aged ≥ 40 and ≤ 65 years with a history of type 2 diabetes (T2D) with a confirmed diagnosis of diabetic neuropathic pain were included in the study. The primary efficacy endpoint was to assess the effect of the 42 days administration of the Nerve Support Formula on the neuropathic pain as assessed by the 11 point Pain Intensity Numeric Rating Scale (PI-NRS). The secondary objectives were to assess the effect on plasma vitamin B12 levels, nerve conduction velocity, blood flow velocity, Brief Pain Inventory, Neuropathy Total Symptom Score, and Insomnia Severity Index.Results: The enrolled study population (n=59) was randomized in two study groups; the Investigational Product (IP) group - Nerve Support Formula (n=27) and placebo group (n=32). The mean age of these participants was 52.63 and 53.72 for IP and placebo group, respectively. The mean (SD) HbA1c levels for IP and placebo group were 8.37 (0.85) and 8.16 (0.86), respectively. By the end of the study (Day 42) the decrease in PI-NRS scores for the IP group was maximal (↓ 61.32%) and highly significant (p< 0.001) in comparison to the placebo group (↑ 2.47%). Significant improvements (p< 0.05) were also noted in the secondary efficacy variables after 42 days of IP intake.Conclusion: The formula was found to be significantly effective as compared to placebo in reducing pain and other sensory symptoms related to the diabetic peripheral neuropathy.Keywords: diabetes mellitus, neuropathic pain, supplements, vitamin B12, placebo controlled