The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Numeric pain scale (0-10) for immediate relief
研究概览
简要总结
The purpose of this study is to determine if the use of Neuragen (a natural health product oil rubbed into the skin) is effective at reducing pain and improving the quality of life in people with diabetic peripheral neuropathy.
详细描述
Incidence of diabetic neuropathy and development of diabetic ulcers varies based on the severity (lack of blood sugar control) and duration of diabetes. Estimates of rates of occurrence vary although one prospective study showed 7.2% of newly diagnosed ulcer-free diabetics developed ulcers within one year of being diagnosed. Current treatment initiatives aimed at educating diabetic patients on how to prevent diabetic ulcers and mange peripheral neuropathy have had varied success. Chronic pain is the number one reason that this population seeks help from medical professionals. Diabetics are particularly predisposed to a potentially disabling form of chronic pain known as peripheral neuropathy. In fact, over 50% of diabetics have painful neuropathy, or will develop this condition. Other than the primary goal of addressing blood sugar levels, conventional treatment of diabetic peripheral neuropathy involves prescription gabapentanoids or opiod analgesics, both of which have considerable cost and may be associated with side effects from long-term use and overall limited success rates. Neuragen is an over-the-counter natural health product that may be a safe and effective treatment option for this disease. Using a randomized double-blind placebo control clinical trial the effects of Neuragen on pain, function and quality of life will be assessed.
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
- Triple (Participant, 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
- •Men and women of at least 18 years of age
- •Established diagnosis of neuropathic pain for at least the past 3 months duration, and type 1 or type 2 diabetes, confirmed by primary care physician and/or neurologist. By signing the informed consent, participants agree to have the study coordinator contact their physician for confirmation of diagnosis.
- •Pain of at least level 4 on a 0-10 scale, and not over 9, despite other treatments on intake.
- •Presence of dynamic tactile allodynia or pinprick hyperalgesia
- •Normal cognitive and communication skills (as judged by investigator) and ability to complete self-report questionnaires.
排除标准
- •Pregnancy
- •Previous or continuing use of Neuragen®
- •Evidence of other types of pain as, or more severe, than the pain under study
- •Major psychological conditions requiring treatment
- •History of eczema/atopy/anaphylaxis or unusual skin reactions. This will be assessed using a subjective question (Have you ever suffered from eczema? Or experienced a skin reaction to a substance? Or experienced an anaphylactic reaction?)
- •Self reported sensitivity to perfumes, essential oils, odors.
- •Changes to current pain management regime within the previous month prior to start of study.
结局指标
主要结局
Numeric pain scale (0-10) for immediate relief
时间窗: Baseline compared to average daily measure over 3 months
Brief Pain Inventory for sustained relief
时间窗: Baseline to month 3
次要结局
- Adverse event reports(Baseline to 3 months)
- Liver enzyme - ALT(Baseline to 3 months)
- Liver enzyme - GGT(Baseline to 3 months)
- Neurologic impairment scale LL +7(Baseline to 3 months)
- Liver enzyme - AST(Baseline to 3 months)
- NeuroQol-97 quality of life measurement questionnaire(Baseline to 3 months)
- Amount of medication used(Baseline to 3 months)
研究者
Kieran Cooley
Associate Director, Research
The Canadian College of Naturopathic Medicine