NCT07028528招募中2 期
A Randomized Placebo Controlled Trial Assessing the Efficacy of Levagen+ for Treating Symptoms of Diabetic Peripheral Neuropathy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline to the end of the study period in overall severity of neuropathic pain
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN.
Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years.
- •Using prescribed glucose-lowering medications, including oral medications (stable dose for 3 months or more) and/or insulin for diabetes (type 1 or 2).
- •Scoring12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
- •Able to provide informed consent.
- •Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.
- •Agree to not participate in another clinical trial during the study period.
- •Able to attend an ACL collection centre.
排除标准
- •Peripheral neuropathy due to causes other than diabetes mellitus (e.g. nutritional deficiencies; hereditary sensory neuropathy; paraneoplastic diseases; advanced liver disease; kidney disease; hypothyroidism; prolonged phenytoin, warfarin or immunosuppressive drug use; active infection [HIV, Lyme disease, Epstein-Barr virus, Hepatitis C, Shingles, Leprosy]; autoimmune disease [Sjogren syndrome, Lupus, Rheumatoid arthritis, Guillain-Barre syndrome]; trauma / injury; toxins [heavy metals, chemicals]; antibiotics; or inflammatory conditions [vasculitis]).
- •Serious illness e.g., paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, or heart conditions, or peripheral vascular disease
- •Unstable illness e.g., diabetes and thyroid gland dysfunction, hypercholesterolemia
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- •Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
- •Herbal medicines for pain relief including, but not limited to, medicinal cannabis, willow bark (Salix alba), Boswellia (Boswellia serrata) or turmeric/curcumin (Curcuma longa).
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
- •Chronic past and/or current alcohol use (>14 alcoholic drinks per week)
- •Females attempting to conceive, pregnant or lactating
- •Allergic, sensitive or intolerant to any of the ingredients in active or placebo formula.
- •Difficulty swallowing capsules.
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
结局指标
主要结局
Change from baseline to the end of the study period in overall severity of neuropathic pain
时间窗: Baseline to week 12
Change from baseline to the end of the study period in overall severity of neuropathic pain, as assessed by the Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy (BPI-DPN). This is a self-reported scale, higher scores indicate greater pain and interference.
次要结局
- Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory(Baseline to week 12)
- Change from baseline to the end of the study period in Safety via Adverse Event reporting(Baseline to week 12)
- Change from baseline to the end of the study period in Safety Markers (FBC)(Baseline to week 12)
- Change from baseline to the end of the study period in Safety Markers (E/LFT)(Baseline to week 12)
- Change from baseline to the end of the study period in Safety (Vitals - BP)(Baseline to week 12)
- Change from baseline to the end of the study period in Safety (Vitals - heart rate)(Baseline to week 12)
- Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep)(Baseline to week 12)
- Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21)(Baseline to week 12)
- Change from baseline to the end of the study period in Glycaemic control (HbA1c)(Baseline to week 12)
- Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose)(Baseline to week 12)
- Change from baseline to the end of the study period in Anthropometry (weight)(Baseline to week 12)
- Change from baseline to the end of the study period in Anthropometry (height)(Baseline to week 12)
- Change from baseline to the end of the study period in Anthropometry (BMI)(Baseline to week 12)
- Change from baseline to the end of the study period in use of rescue medication for pain(Baseline to week 12)
研究者
研究点 (2)
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