[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647438":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Thammasat University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Benfotiamine","EXPERIMENTAL","Parcipitant in this arm will recieve benfotiamine 300 mg per day",[13],"Drug: Benfotiamine",{"label":15,"type":16,"description":17,"interventionNames":18},"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)",[19],"Drug: Vitamin B1-6-12",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","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.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Vitamin B1-6-12","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.",[15],[31],{"name":32,"affiliation":33,"role":34},"Supitcha Lamlertpanya","Faculty of pharmacy Thammasat","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+66972723880","supicha.lam0901@gmail.com",{"name":41,"role":37,"phone":42,"phoneExt":43,"email":44},"Arom Jedsadayanmata","+6629869214","4384","aromj@tu.ac.th",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":25,"geoPoint":25,"contacts":54},"Thammasat University Hospital","RECRUITING","Pathumthani","Bangkok","12120","Thailand","TH",[55],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},{"type":34,"investigatorFullName":32,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator",[59],{"name":60,"class":61},"Wörwag Pharma GmbH & Co. KG","UNKNOWN","100647438","phase-4-benfotiamine-versus-vitamin-b1-6-12-for-diabetic-peripheral-neuropathy-100647438",false,"NCT07708233","Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy","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","Inclusion Criteria:\n\n* Age ≥18 years.\n* 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:\n\nM79.2: Neuralgia and neuritis, unspecified; or G62.9: Polyneuropathy, unspecified.\n\n* 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.\n* No evidence of vitamin B12 deficiency, defined as a serum vitamin B12 level ≥200 pg\u002FmL (148 pmol\u002FL).\n* provide informed consent and participate in the study.\n\nExclusion Criteria:\n\n* Presence of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltose malabsorption.\n* 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.\n* Presence of other conditions that may affect diabetic peripheral neuropathy or neuropathic pain, including:\n\n  * 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.\n  * HIV\u002FAIDS with any of the following: Current or previous treatment with didanosine, stavudine, or zalcitabine; CD4 count \\\u003C200 cells\u002Fmm³; or HIV viral load \\>1,000 copies\u002FmL.\n  * Drug-induced polyneuropathy (ICD-10: G62.0).\n  * Polyneuropathy due to other toxic agents (ICD-10: G62.2).\n  * Alcoholic polyneuropathy (ICD-10: G62.1).\n  * Fibromyalgia (ICD-10: M79.7).\n  * Planned surgery within 3 months prior to or during the study period.\n  * Previous pain-relief procedures, including:\n* Transcutaneous electrical nerve stimulation (TENS) or temporary peripheral nerve stimulation (PNS) within 1 year prior to enrollment;\n* Permanent PNS;\n* Pulsed radiofrequency or radiofrequency ablation within 6 months prior to enrollment;\n* Botulinum toxin injection for neuropathic pain relief within 12 weeks prior to enrollment.\n* Adjustment of glucose-lowering medication doses or HbA1c \\>8% within 3 months prior to study enrollment.\n* Pregnancy, planned pregnancy within 3 months, or currently breastfeeding.\n* Inability to attend scheduled study visits in person or through telemedicine follow-up as required by the study protocol.\n* Known allergy or hypersensitivity to benfotiamine or any component of benfotiamine, vitamin B1, vitamin B6, or vitamin B12.\n* Previous use of benfotiamine and\u002For vitamin B1-6-12 discontinued less than 7 days before study enrollment.\n* Current use of vitamin B6 supplementation or medications containing vitamin B6 at a dose \\>100 mg\u002Fday.","ALL","18 Years",{"count":72,"type":73},66,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","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.\n\nThe main questions this study aims to answer are:\n\n* Does benfotiamine reduce overall sensory neuropathy symptoms more effectively than vitamin B1-6-12?\n* Does benfotiamine reduce numbness more effectively than vitamin B1-6-12?\n* Does benfotiamine reduce pain more effectively than vitamin B1-6-12?\n\nResearchers 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.\n\nThe 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.\n\nParticipants will:\n\n* undergo screening for vitamin B12 deficiency before enrollment. Patients with vitamin B12 deficiency will not be eligible for participation.\n* randomly assigned to receive either benfotiamine or vitamin B1-6-12, taken orally twice daily for 3 months.\n* attend two on-site clinic visits (baseline and the end of the study) and complete two telephone follow-up assessments during the study.\n* 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.",[79],"Diabetic Peripheral Neuropathy (DPN)",[81,82,83,84],"benfotiamine","Vitamin B","Daibetic neuropathy","diabetic peripheral neuropathy","2026-07-18",{"date":87,"type":88},"2026-07-21","ACTUAL",{"date":90,"type":88},"2026-07-14",{"date":92,"type":73},"2027-06-30",{"name":5,"class":6},1]