Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy
In plain words A Phase 4 study of benfotiamine in people 18 and older, run by Thammasat University. It plans to enroll about 66 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Diabetic Peripheral Neuropathy (DPN).
- Age ≥18 years.
- Diagnosis of diabetic peripheral neuropathy confirmed by a physician based on the following ICD-10 codes: E11.42: Type 2 diabetes mellitus with diabetic polyneuropathy; or E11: Type 2 diabetes mellitus, combined with either:
- Presence of sensory neuropathy symptoms assessed using the Neuropathy Total Symptom Score-6 (NTSS-6), with: Total NTSS-6 score ≥1; and Numbness symptom score (NTSS-6 item 6) ≥1.
- No evidence of vitamin B12 deficiency, defined as a serum vitamin B12 level ≥200 pg/mL (148 pmol/L).
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Benfotiamine; Vitamin B1-6-12
Registered summary
The purpose of this clinical trial is to compare the efficacy of benfotiamine with vitamin B1-6-12 in reducing sensory neuropathy symptoms, numbness and pain in patients with diabetic peripheral neuropathy. The main questions this study aims to answer are: * Does benfotiamine reduce overall sensory neuropathy symptoms more effectively than vitamin B1-6-12? * Does benfotiamine reduce numbness more effectively than vitamin B1-6-12? * Does benfotiamine reduce pain more effectively than vitamin B1-6-12? Researchers will compare benfotiamine with vitamin B1-6-12 in a double-blind study. The full summary is on the listing.
Where, as registered
No US site; Thailand (1).