About this trial
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. Both treatments will be manufactured as visually identical study medications to maintain blinding.
The study will evaluate whether benfotiamine provides greater improvement in sensory neuropathy symptoms, numbness, and pain than vitamin B1-6-12 in patients with diabetic peripheral neuropathy.
Participants will:
* undergo screening for vitamin B12 deficiency before enrollment. Patients with vitamin B12 deficiency will not be eligible for participation. * randomly assigned to receive either benfotiamine or vitamin B1-6-12, taken orally twice daily for 3 months. * attend two on-site clinic visits (baseline and the end of the study) and complete two telephone follow-up assessments during the study. * continue their usual medications throughout the study, provided that no new neuropathic pain medications are initiated and the dose of existing neuropathic pain medications remains unchanged.
Eligibility criteria
Qualifiers
Age ≥18 years.
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).
provide informed consent and participate in the study.
Disqualifiers
Presence of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltose malabsorption.
Adjustment of doses of medications used for neuropathic pain control within 6 weeks prior to study enrollment, including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentinoids, or other neuropathic pain medications.
Chemotherapy-induced peripheral neuropathy due to neurotoxic agents within 6 months prior to enrollment, including vinca alkaloids, taxanes, platinum-based agents, proteasome inhibitors, thalidomide, brentuximab vedotin, or ado-trastuzumab emtansine.
HIV/AIDS with any of the following: Current or previous treatment with didanosine, stavudine, or zalcitabine; CD4 count <200 cells/mm³; or HIV viral load >1,000 copies/mL.
Trial design
Treatments tested in this trial
- Benfotiamine
- Vitamin B1-6-12
Treatment groups
Locations
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Sponsors and collaborators
Thammasat University
Lead sponsor
Wörwag Pharma GmbH & Co. KG
Collaborator