Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAzienda di Servizi alla Persona di Pavia

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

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations