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

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.