Diabetic Neuropathies, Painful, Neuropathic Pain Management, Palmitoylethanolamide
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTCronilief™ (300 mg)
* Week 1: Cronilief™ (300 mg), 2 tablets per day, single administration * Weeks 2-8: Cronilief™ (300 mg), 1 tablet per day
DIETARY_SUPPLEMENTPlacebo
* Week 1: Placebo, 2 tablets per day, single administration * Weeks 2-8: Placebo, 1 tablet per day.
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate specific symptoms of neuropathic pain in diabetic subjects | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate sleep quality | 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. |
| Evaluate emotional states | 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). |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Outcome results
None listed