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临床试验/NCT02475564
NCT02475564已完成4 期

The Use of Resveratrol for Pain in Endometriosis - A Clinical Trial

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
44
试验地点
1
主要终点
Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.

研究概览

简要总结

This study aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo.

详细描述

Endometriosis is a disease that affects 176 million women around the world, and it is present in about 60% of adolescent women with chronic pelvic pain and dysmenorrhea. Some researchers have investigated the antiproliferative effect of resveratrol in endometriosis using animal models and humans. The reduction in the size and activity of the endometriotic implants has been observed with the use of resveratrol. The reduction of pain in patients with endometriosis is an important aspect of the quality of life. The use of a medication with few side effects and the lack of clinical quality trials justify this study, which aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo. This study will be randomized, prospective, double blind with two arms of 22 patients; the CONSORT parameters will be followed. The degree of pain by visual analog scale, prolactin levels (ng / mL) and the carcinoembryonic antigen levels (CA125) (IU / L) will be measured at the begging and at the end of trial. These parameters will be the outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Endometriosis diagnosed by laparoscopy

排除标准

  • Known allergy to resveratrol
  • Use of gonadotropin or danazol in the last month

研究组 & 干预措施

placebo

Placebo Comparator

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)

干预措施: Placebo (Drug)

resveratrol

Experimental

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol

干预措施: Resveratrol (Drug)

结局指标

主要结局

Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.

时间窗: 42 days

Pain will be measured by VAS (visual analog scale) as baseline and at the end of the study, considering the last 7 days. VAS was used to measuring pain intensity, ranging continuously from 0 (no pain) to 10 (worst imaginable pain). The main outcome compared median pain levels between both arms on day 42.

次要结局

  • Serum Prolactin Levels at 42 Days(42 days)
  • Serum CA125 Levels at 42 Days(42 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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