A Phase 4 interventional study of Benfotiamine and Vitamin B1-6-12 in Diabetic Peripheral Neuropathy (DPN), sponsored by Thammasat University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Thammasat University · Phase 4, Interventional, and Treatment
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:
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:
Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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M79.2: Neuralgia and neuritis, unspecified; or G62.9: Polyneuropathy, unspecified.
Exclusion Criteria:
Presence of other conditions that may affect diabetic peripheral neuropathy or neuropathic pain, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Parcipitant in this arm will recieve benfotiamine 300 mg per day
Drug: Benfotiamine
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
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.
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.
Mean change NTSS-6
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) Maximum score 21.96 Minimum score 0 which higher score represent more severity of sensory neuropathy symptoms. Minimally clinically important differences (MCIDs) is different between group 1.26 points.
Time frame: From enrollment to 4, 8 and 12 weeks of treatment.
Mean change of numbness score
Numbness was assessed using a Numerical Rating Scale (NRS). The numbness scale underwent content validity assessment by three experts and achieved an Item-Objective Congruence (IOC) score of 1.0. Scores range from 0 to 10, with higher scores indicating greater numbness severity.
Time frame: From enrollment to the end of treatment at 12 weeks
Mean change numerical rating scale for pain
Pain was assessed using a Numerical Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater pain severity.
Time frame: 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
Plan to share: No — Individual participant data will not be made available to others.
Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.
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Studies of the drug tested here: Benphothiamine
Thammasat University