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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean change NTSS-6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≥
- •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.
排除标准
- •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 B
- •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.
研究组 & 干预措施
Vitamin B 1-6-12
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)
干预措施: Vitamin B1-6-12 (Drug)
Benfotiamine
Parcipitant in this arm will recieve benfotiamine 300 mg per day
干预措施: Benfotiamine (Drug)
结局指标
主要结局
Mean change NTSS-6
时间窗: 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.
次要结局
- The proportion (%) of participants who achieved a Patient Global Impression of Change (PGIC) score of 1-2(From enrollment to the end of treatment at 12 weeks)
- Mean change numerical rating scale for pain(From enrollment to 4, 8 and 12 weeks of treatment at)
- Mean change of numbness score(From enrollment to the end of treatment at 12 weeks)
研究者
Supitcha Lamlertpanya
Principal Investigator
Thammasat University