Loading clinical trials...

Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain. | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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.

NCT07377409•Azienda di Servizi alla Persona di Pavia

View on ClinicalTrials.gov

Summary

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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;
+3 more criteria

Key Dates

Start Date

September 15, 2026

Primary Completion Date

December 15, 2026

Completion Date

January 15, 2027

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Neuropathic Pain ManagementDiabetic Neuropathies, PainfulPalmitoylethanolamide

Interventions

Cronilief™ (300 mg)

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Graded Exposure in Patients With Painful Diabetic Neuropathy

NCT03066570

Painful Diabetic NeuropathyDiabetic Neuropathies, Painful+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions