About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Cronilief™ (300 mg)
- Placebo