Randomised, Placebo-controlled Study to Evaluate the Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids), in Addition to Standard Therapy, in Diabetic Subjects With Neuropathic Pain.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Evaluate specific symptoms of neuropathic pain in diabetic subjects
研究概览
简要总结
This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Satisfactory metabolic compensation;
- •Presence of moderate symptoms of painful diabetic neuropathy as assessed by the LANSS questionnaire (score ≥12);
- •Taking antidiabetic drugs except insulin;
- •Subjects willing and able to comply with scheduled study visits, the treatment plan, and all procedures outlined in the study.
排除标准
- •Previous intolerance to a component of the nutraceuticals tested;
- •Individuals with type I diabetes;
- •Uncontrolled diabetes, severe cardiovascular and cerebrovascular diseases;
- •Severe neuropathic symptoms as indicated by the LANSS score;
- •Individuals undergoing insulin treatment;
- •Peripheral neuropathy due to diseases other than diabetes mellitus;
- •History of malignant neoplasm in the 5 years prior to enrolment in the study;
- •Serious neurological, psychological or psychiatric disorders;
- •Clinical signs or history of significant impairment of hepatic or renal function, peptic ulcer or coagulation disorders;
- •Any clinically relevant or unstable disease (e.g., active malignancies, immune system disorders) whose sequelae or treatments could contraindicate participation in the study or interfere with the study's evaluation parameters, in the investigator's judgement; Any disease that could significantly affect the study's outcome, including, but not limited to, chronic medical conditions, psychological disorders, or substance abuse;
- •Alcohol or drug abuse;
- •Women of childbearing age who do not use established contraceptive methods;
- •Pregnancy and breastfeeding.
研究组 & 干预措施
Group A: Cronilief™ supplementation
Cronilief™ (300 mg) supplementation
干预措施: Cronilief™ (300 mg) (Dietary Supplement)
Group B: Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Evaluate specific symptoms of neuropathic pain in diabetic subjects
时间窗: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
Evaluate the effectiveness of Cronilief™ supplementation versus placebo, in combination with standard therapy, in improving specific symptoms of neuropathic pain in diabetic subjects after 8 weeks of supplementation, using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire as an assessment tool. The LANSS score ranges from 0 to 24, with higher scores indicating a greater neuropathic pain component (worse outcome). A score ≥12 is indicative of neuropathic pain.
次要结局
- Evaluate sleep quality(Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration)
- Evaluate emotional states(Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration)