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

Официальное название

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.

Обзор

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.

Вмешательства

• Пищевая добавка Cronilief™ (300 mg)
  * Week 1: Cronilief™ (300 mg), 2 tablets per day, single administration * Weeks 2-8: Cronilief™ (300 mg), 1 tablet per day
• Пищевая добавка Placebo
  * Week 1: Placebo, 2 tablets per day, single administration * Weeks 2-8: Placebo, 1 tablet per day.

Первичные конечные точки

• Evaluate specific symptoms of neuropathic pain in diabetic subjects [Срок оценки: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration]

Вторичные конечные точки (3)

• Evaluate sleep quality [Срок оценки: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration]
• Evaluate emotional states [Срок оценки: 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) [Срок оценки: Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07377409 · 1812/28082025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗