Diabetic Peripheral Neuropathy (DPN)Phase 4NCT07708233
Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy
A Phase 4 study testing Benfotiamine and Vitamin B1-6-12 in people with Diabetic Peripheral Neuropathy (DPN), run by Thammasat University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Benfotiamine and Vitamin B1-6-12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- 14 Jul 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Thammasat University Hospital
Pathumthani, Bangkok, 12120
Supitcha Lamlertpanya, +66972723880, supicha.lam0901@gmail.com
About this study
Official title: 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:
Read more
- 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)
- Being tested
- Benfotiamine, Vitamin B1-6-12
- Keywords
- benfotiamine, Vitamin B, Daibetic neuropathy, diabetic peripheral neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenfotiamineDrug
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 B1-6-12Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Benfotiamine | Experimental | Parcipitant in this arm will recieve benfotiamine 300 mg per day Receives: Drug: Benfotiamine |
| Vitamin B 1-6-12 | Active comparator | 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) Receives: Drug: Vitamin B1-6-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 4, 8 and 12 weeks of treatment.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start14 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Collaborators
- Wörwag Pharma GmbH & Co. KG
- Responsible party
- Principal investigator, Supitcha Lamlertpanya, Thammasat University
- Investigators
- Supitcha Lamlertpanya, Principal investigator, Faculty of pharmacy Thammasat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708233
- Sponsor's protocol ID
- 68PH174
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to others.
Publications
Management of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1, B6 and B12: A 12-week prospective non-interventional study in Indonesia. (2018). Asian Journal of Medical Sciences, 9(1), 32-40. https://doi.org/10.3126/ajms.v9i1.18510
The Role of Vitamins B Complex in the Management of Diabetic Peripheral Neuropathy: an Electrophysiological Study. (2024). The Review of Diabetic Studies , 19(3). https://diabeticstudies.org/index.php/RDS/article/view/370
Sathienluckana T, Palapinyo S, Yotsombut K, Wanothayaroj E, Sithinamsuwan P, Suksomboon N. Expert consensus guidelines for community pharmacists in the management of diabetic peripheral neuropathy with a combination of neurotropic B vitamins. J Pharm Policy Pract. 2024 Feb 7;17(1):2306866. doi: 10.1080/20523211.2024.2306866. eCollection 2024.
PubMed 38333576Gerould H, Mangrum R, Robinson RL, Schantz K, Bryant A, Delbecque L, Behrend B, Price KL, Stauffer VL, Secinti E. Evaluating the Content Validity of the Modified Neuropathy Total Symptom Score-6 Self-Administered (mNTSS-6-SA) in a Painful Diabetic Peripheral Neuropathy Population. J Pain Res. 2025 Nov 12;18:6045-6055. doi: 10.2147/JPR.S539056. eCollection 2025.
PubMed 41257214Bastyr EJ 3rd, Price KL, Bril V; MBBQ Study Group. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94. doi: 10.1016/j.clinthera.2005.08.002.
PubMed 16199253Ziegler D, Tesfaye S, Spallone V, Gurieva I, Al Kaabi J, Mankovsky B, Martinka E, Radulian G, Nguyen KT, Stirban AO, Tankova T, Varkonyi T, Freeman R, Kempler P, Boulton AJ. Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Diabetes Res Clin Pract. 2022 Apr;186:109063. doi: 10.1016/j.diabres.2021.109063. Epub 2021 Sep 20.
PubMed 34547367Balakumar P, Rohilla A, Krishan P, Solairaj P, Thangathirupathi A. The multifaceted therapeutic potential of benfotiamine. Pharmacol Res. 2010 Jun;61(6):482-8. doi: 10.1016/j.phrs.2010.02.008. Epub 2010 Feb 25.
PubMed 20188835Bozic I, Lavrnja I. Thiamine and benfotiamine: Focus on their therapeutic potential. Heliyon. 2023 Nov 7;9(11):e21839. doi: 10.1016/j.heliyon.2023.e21839. eCollection 2023 Nov.
PubMed 38034619Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. doi: 10.2337/dc11-1895. Epub 2012 Mar 23.
PubMed 22446172Haupt E, Ledermann H, Kopcke W. Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study). Int J Clin Pharmacol Ther. 2005 Feb;43(2):71-7. doi: 10.5414/cpp43071.
PubMed 15726875Stracke H, Gaus W, Achenbach U, Federlin K, Bretzel RG. Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study. Exp Clin Endocrinol Diabetes. 2008 Nov;116(10):600-5. doi: 10.1055/s-2008-1065351. Epub 2008 May 13.
PubMed 18473286
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07708233
- Acronym / sponsor ID
- 68PH174
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- benfotiamine, Vitamin B, Daibetic neuropathy, diabetic peripheral neuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Collaborators
- Wörwag Pharma GmbH & Co. KG
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benfotiamine | Experimental | Drug: BenfotiamineParcipitant in this arm will recieve benfotiamine 300 mg per day |
| Vitamin B 1-6-12 | Active comparator | Drug: Vitamin B1-6-12Parcipitant in this arm will recieve Vitamin B1-6-12 combined pill (total B1 200 mg, B6 10 mg and B12 130 mcg per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (21 listed)
- 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:
- Transcutaneous electrical nerve stimulation (TENS) or temporary peripheral nerve stimulation (PNS) within 1 year prior to enrollment;
- Permanent PNS;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenfotiamineBenfotiamine 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 | Benfotiamine |
| Vitamin B1-6-12Vitamin 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. | Drug | Vitamin B 1-6-12 |
Primary outcome
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) 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.
3 secondary outcomes
Mean change of numbness score
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- BackgroundManagement of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1, B6 and B12: A 12-week prospective non-interventional study in Indonesia. (2018). Asian Journal of Medical Sciences, 9(1), 32-40. https://doi.org/10.3126/ajms.v9i1.18510
- BackgroundThe Role of Vitamins B Complex in the Management of Diabetic Peripheral Neuropathy: an Electrophysiological Study. (2024). The Review of Diabetic Studies , 19(3). https://diabeticstudies.org/index.php/RDS/article/view/370
- Background: PubMed 38333576Sathienluckana T, Palapinyo S, Yotsombut K, Wanothayaroj E, Sithinamsuwan P, Suksomboon N. Expert consensus guidelines for community pharmacists in the management of diabetic peripheral neuropathy with a combination of neurotropic B vitamins. J Pharm Policy Pract. 2024 Feb 7;17(1):2306866. doi: 10.1080/20523211.2024.2306866. eCollection 2024.
- Background: PubMed 41257214Gerould H, Mangrum R, Robinson RL, Schantz K, Bryant A, Delbecque L, Behrend B, Price KL, Stauffer VL, Secinti E. Evaluating the Content Validity of the Modified Neuropathy Total Symptom Score-6 Self-Administered (mNTSS-6-SA) in a Painful Diabetic Peripheral Neuropathy Population. J Pain Res. 2025 Nov 12;18:6045-6055. doi: 10.2147/JPR.S539056. eCollection 2025.
- Background: PubMed 16199253Bastyr EJ 3rd, Price KL, Bril V; MBBQ Study Group. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94. doi: 10.1016/j.clinthera.2005.08.002.
- Background: PubMed 34547367Ziegler D, Tesfaye S, Spallone V, Gurieva I, Al Kaabi J, Mankovsky B, Martinka E, Radulian G, Nguyen KT, Stirban AO, Tankova T, Varkonyi T, Freeman R, Kempler P, Boulton AJ. Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Diabetes Res Clin Pract. 2022 Apr;186:109063. doi: 10.1016/j.diabres.2021.109063. Epub 2021 Sep 20.
- Background: PubMed 20188835Balakumar P, Rohilla A, Krishan P, Solairaj P, Thangathirupathi A. The multifaceted therapeutic potential of benfotiamine. Pharmacol Res. 2010 Jun;61(6):482-8. doi: 10.1016/j.phrs.2010.02.008. Epub 2010 Feb 25.
- Background: PubMed 38034619Bozic I, Lavrnja I. Thiamine and benfotiamine: Focus on their therapeutic potential. Heliyon. 2023 Nov 7;9(11):e21839. doi: 10.1016/j.heliyon.2023.e21839. eCollection 2023 Nov.
- Background: PubMed 22446172Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. doi: 10.2337/dc11-1895. Epub 2012 Mar 23.
- Background: PubMed 15726875Haupt E, Ledermann H, Kopcke W. Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study). Int J Clin Pharmacol Ther. 2005 Feb;43(2):71-7. doi: 10.5414/cpp43071.
- Background: PubMed 18473286Stracke H, Gaus W, Achenbach U, Federlin K, Bretzel RG. Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study. Exp Clin Endocrinol Diabetes. 2008 Nov;116(10):600-5. doi: 10.1055/s-2008-1065351. Epub 2008 May 13.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to others.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Supitcha Lamlertpanya principal investigator
Faculty of pharmacy Thammasat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benfotiamine and Vitamin B1-6-12 in people with Diabetic Peripheral Neuropathy (DPN), run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Supitcha Lamlertpanya (+66972723880, supicha.lam0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change NTSS-6 (time frame: From enrollment to 4, 8 and 12 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07708233, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.