ACTRN12620001302943已完成未知
A randomised, double-blind, placebo-controlled study evaluating Palmitoylethanolamide for diabetic-related peripheral neuropathic pain, inflammation and quality of life
Gencor Pacific Ltd0 个研究点目标入组 70 人开始时间: 2020年12月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Male and female participants aged 18 years and above
- •Diagnosed with type 1 diabetes or type 2 diabetes
- •Currently prescribed medications for diabetes, including metformin and/or insulin
- •Have been medically diagnosed with peripheral neuropathy
- •Experiencing neuropathic pain for > 3 months
- •Score >4 on Neuropathic Pain Diagnostic Questionnaire (DN4) OR Score >12 on Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (s-LANSS).
- •Participants who can provide informed consent.
排除标准
- •Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put participant at risk of adverse events.
- •Potential for peripheral neuropathy due to the following causes will be excluded: hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, prolonged phenytoin or immunosuppressive drug use.
- •Pregnant, planning to become pregnant or breastfeeding women.
- •Those with alcohol or substance abuse health issues.
- •Allergy or sensitivity to any of the ingredients in the investigational products.
研究者
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