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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Neuropathies, Painful; Neuropathic Pain Management; Palmitoylethanolamide
• Intervention / Treatment: Dietary supplement: Cronilief™ (300 mg); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Cronilief™ supplementation; Cronilief™ (300 mg) supplementation	Dietary supplement: Cronilief™ (300 mg); Week 1: Cronilief™ (300 mg), 2 tablets per day, single administration; Weeks 2-8: Cronilief™ (300 mg), 1 tablet per day
Placebo Comparator: Group B: Placebo; Placebo	Dietary supplement: Placebo; Week 1: Placebo, 2 tablets per day, single administration; Weeks 2-8: Placebo, 1 tablet per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration
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).	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)	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.	Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies
• Other Study ID Numbers: 1812/28082025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No