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

NCT07708233 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-07-21

No results posted yet for this study

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. 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.

Conditions

  • Diabetic Peripheral Neuropathy (DPN)

Interventions

DRUG

Benfotiamine

Benfotiamine arm - participants receive benfotiamine 150 mg orally twice daily for 3 months. Benfotiamine is provided as blinded study medication that is visually identical to the comparator to maintain double blinding.

DRUG

Vitamin B1-6-12

Vitamin B1-6-12 arm- participants receive vitamin B1-6-12 (B1 100 mg, B6 5 mg, B12 65 mcg per tablet) orally twice daily for 3 months. The study medication is manufactured to be visually identical to benfotiamine to maintain double blinding.

Sponsors & Collaborators

  • Wörwag Pharma GmbH & Co. KG

    collaborator UNKNOWN

  • Thammasat University

    lead OTHER

Principal Investigators

  • Supitcha Lamlertpanya · Faculty of pharmacy Thammasat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-14
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708233 on ClinicalTrials.gov