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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
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.
Thammasat University Hospital
Pathumthani, Bangkok, Thailand
RECRUITINGMean 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
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