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Not yet recruiting NCT07377409

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

No phase Interventional Neuropathic Pain Management Diabetic Neuropathies, Painful Palmitoylethanolamide

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cronilief™ (300 mg), Placebo.
Who it may be relevant to
Registry conditions: Neuropathic Pain Management, Diabetic Neuropathies, Painful, Palmitoylethanolamide. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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 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
  • Dietary supplement Placebo
    * Week 1: Placebo, 2 tablets per day, single administration * Weeks 2-8: Placebo, 1 tablet per day.

Primary outcome measures

  • Evaluate specific symptoms of neuropathic pain in diabetic subjects [Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration]
Secondary outcome measures (3)
  • Evaluate sleep quality [Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration]
  • Evaluate emotional states [Time frame: 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) [Time frame: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07377409 · 1812/28082025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗