Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of Pelvic pain as measured by visual analogue scale
研究概览
简要总结
One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia.
N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 50 years;
- •pain visual analog scale (VAS) score>4
- •laparoscopic diagnosis of endometriosis (performed in the last three years),
- •no assumption of any drugs (in particularly estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists)
- •persistence of symptoms by at least one month
排除标准
- •presence of other associated diseases
- •assumption of drugs
- •menopause
- •pregnancy
- •unable or unwilling to give written consent patients
- •adverse reaction or hypersensitivity to active substance or excipients
研究组 & 干预措施
Endometriosis
Symptomatic patients with laparoscopic diagnosis of endometriosis
干预措施: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin (Drug)
结局指标
主要结局
Change of Pelvic pain as measured by visual analogue scale
时间窗: Change from Baseline Pelvic Pain at 90 days of treatment
次要结局
- Change of Pelvic pain as measured by visual analogue scale(Change from baseline Pelvic Pain after 30 days from the suspension of the therapy)
研究者
Stefano Angioni
Associate Professor
University of Cagliari