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NCT Number: NCT07377409

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

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.

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Key information

Conditions

Neuropathic Pain Management Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathies, Painful Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Palmitoylethanolamide Peripheral Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluate specific symptoms of neuropathic pain in diabetic subjects

    Time frame: 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.

Secondary outcomes

  1. Evaluate sleep quality

    Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

    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.

  2. Evaluate emotional states

    Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

    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).

  3. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

    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.

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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