Comparing Benfotiamine and Vitamin B1-6-12 for Reducing Symptoms of Diabetic Peripheral Neuropathy in Adults Over 12 Weeks

What this Trial Is About

Researchers are evaluating the effects of benfotiamine compared to vitamin B1-6-12 in adults with diabetic peripheral neuropathy. This condition causes sensory neuropathy symptoms, numbness, and pain, and the study aims to find out if benfotiamine reduces these symptoms more effectively than vitamin B1-6-12. The trial is a phase 4, randomized, double-blind study designed to compare these treatments over 12 weeks. Participants will be randomly assigned to one of two groups one receiving benfotiamine 150 mg twice daily, and the other receiving a combined vitamin B1 100 mg, B6 5 mg, and B12 65 mcg pill twice daily. Both treatments are given orally for three months and are made to look identical to keep the study blinded. Before enrollment, participants will be screened for vitamin B12 deficiency, and those with low levels will not be eligible. During the study, participants will have two in-person clinic visits at the start and end of the 12-week treatment period, along with two telephone follow-ups. They will continue their usual medications as long as no new neuropathic pain treatments are started and existing doses remain stable. Researchers will assess changes in neuropathy symptoms, numbness, and pain over the course of treatment using standardized symptom scores and patient impressions of change.

Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy