Can a vitamin b derivative beat standard b vitamins for diabetic nerve pain?
NCT ID NCT07708233
First seen Jul 16, 2026 · Last updated Jul 22, 2026 · Updated 3 times
Summary
This study tests whether benfotiamine, a form of vitamin B1, works better than a combination of vitamins B1, B6, and B12 at reducing numbness, pain, and other sensory nerve symptoms in people with diabetic peripheral neuropathy. Participants take either benfotiamine or the vitamin mix twice daily for 12 weeks, and neither they nor their doctors know which they receive. The goal is to see if benfotiamine provides greater relief from these common, uncomfortable nerve symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- benfotiamine and vitamin B1-6-12
- What this could lead to
- If benfotiamine proves more effective, it could offer a better option for managing painful nerve symptoms in people with diabetes.
- What could go wrong
- This is a small, short-term study (66 people, 12 weeks). Results may not apply to everyone, and benefits may be modest or no better than the vitamin combination.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Thammasat University Hospital
RECRUITINGPathumthani, Bangkok, 12120, Thailand
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