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.
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.
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;
Parallel
Cronilief™ (300 mg)
Dietary supplement* Week 1: Cronilief™ (300 mg), 2 tablets per day, single administration * Weeks 2-8: Cronilief™ (300 mg), 1 tablet per day
Placebo
Dietary supplement* Week 1: Placebo, 2 tablets per day, single administration * Weeks 2-8: Placebo, 1 tablet per day.
Evaluate specific symptoms of neuropathic pain in diabetic subjects
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.
Evaluate sleep quality
Assess the impact of Cronilief™ supplementation on sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality (poorer outcome). A total score \>5 is indicative of poor sleep quality.
Evaluate emotional states
Assess the impact of Cronilief™ supplementation on emotional states related to stress, anxiety and depression through the administration of the Depression Anxiety Stress Scales (DASS-21). The DASS-21 consists of three subscales (Depression, Anxiety, Stress), each ranging from 0 to 21. Higher scores indicate greater severity of symptoms (worse outcome).
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assess the safety of Cronilief™ by monitoring AEs (Adverse Events) and SAEs (Serious Adverse Events) evaluated by investigators and reported in accordance with current regulations.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
