Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy
- NCT ID
- NCT07708233
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 4
- Sponsor
- Thammasat University
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 66 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
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 locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: Thailand
- Bangkok, Thailand: 1
Sample of listed locations
- Thammasat University Hospital — Pathumthani, Bangkok, 12120, Thailand — Site recruitment status not specified in the registry data
Study details
- Start date
- July 14, 2026
- Primary completion date
- June 30, 2027
- First posted
- July 16, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07708233
- Registry last updated
- July 21, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07708233 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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