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

Azienda di Servizi alla Persona di Pavia

Status

Begins enrollment in 7 months

Conditions

Neuropathic Pain Management

Palmitoylethanolamide

Diabetic Neuropathies, Painful

Treatments

Dietary Supplement: Cronilief™ (300 mg)

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07377409

1812/28082025

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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;
Alcohol or drug abuse;
Women of childbearing age who do not use established contraceptive methods;
Pregnancy and breastfeeding.