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

July 12, 2026 updated by: Supitcha Lamlertpanya, Thammasat University

A 12-Week Double-blind Randomized Controlled Study; Comparing the Efficacy of Benfotiamine and Vitamin b1-6-12 in Alleviating Numbness, Sensory Neuropathy Symptoms and Pain in Patients With Diabetic Peripheral Neuropathy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Arom Jedsadayanmata
  • Phone Number: 4384 +6629869214
  • Email: aromj@tu.ac.th

Study Locations

  • Thailand
    • Bangkok
      • Pathumthani, Bangkok, Thailand, 12120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

M79.2: Neuralgia and neuritis, unspecified; or G62.9: Polyneuropathy, unspecified.

  • 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.

Exclusion Criteria:

  • 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.

  • Presence of other conditions that may affect diabetic peripheral neuropathy or neuropathic pain, including:

    • 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.
    • Drug-induced polyneuropathy (ICD-10: G62.0).
    • Polyneuropathy due to other toxic agents (ICD-10: G62.2).
    • Alcoholic polyneuropathy (ICD-10: G62.1).
    • Fibromyalgia (ICD-10: M79.7).
    • Planned surgery within 3 months prior to or during the study period.
    • Previous pain-relief procedures, including:
  • Transcutaneous electrical nerve stimulation (TENS) or temporary peripheral nerve stimulation (PNS) within 1 year prior to enrollment;
  • Permanent PNS;
  • Pulsed radiofrequency or radiofrequency ablation within 6 months prior to enrollment;
  • Botulinum toxin injection for neuropathic pain relief within 12 weeks prior to enrollment.
  • Adjustment of glucose-lowering medication doses or HbA1c >8% within 3 months prior to study enrollment.
  • Pregnancy, planned pregnancy within 3 months, or currently breastfeeding.
  • Inability to attend scheduled study visits in person or through telemedicine follow-up as required by the study protocol.
  • Known allergy or hypersensitivity to benfotiamine or any component of benfotiamine, vitamin B1, vitamin B6, or vitamin B12.
  • Previous use of benfotiamine and/or vitamin B1-6-12 discontinued less than 7 days before study enrollment.
  • Current use of vitamin B6 supplementation or medications containing vitamin B6 at a dose >100 mg/day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Benfotiamine
Parcipitant in this arm will recieve benfotiamine 300 mg per day
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.
Active Comparator: Vitamin B 1-6-12
Parcipitant in this arm will recieve Vitamin B1-6-12 combined pill (total B1 200 mg, B6 10 mg and B12 130 mcg per day)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change NTSS-6
Time Frame: From enrollment to 4, 8 and 12 weeks of treatment.
Neuropathy Total Symptom Score-6 (NTSS-6) is a score measured severity and frequency of 6 sensory neuropathy symptoms that common in diabetic peripheral neuropathy (numbness, Aching pain, Burning pain, Allodynia, Prickling sensation, Lancinating pain)
From enrollment to 4, 8 and 12 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change of numbness score
Time Frame: From enrollment to the end of treatment at 12 weeks
Assess numbness by using numerical rating scale, this numbness score underwent content validity assessment by three experts and achieved an IOC score of +1.0
From enrollment to the end of treatment at 12 weeks
Mean change numerical rating scale for pain
Time Frame: From enrollment to 4, 8 and 12 weeks of treatment at
From enrollment to 4, 8 and 12 weeks of treatment at
The proportion (%) of participants who achieved a Patient Global Impression of Change (PGIC) score of 1-2
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Collaborators

Wörwag Pharma GmbH & Co. KG

Investigators

  • Principal Investigator: Supitcha Lamlertpanya, Faculty of pharmacy Thammasat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68PH174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available to others.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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