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临床试验/ACTRN12621000015842
ACTRN12621000015842已完成3 期

Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Female Population – A double blind, randomised controlled trial.

RDC Global Pty Ltd0 个研究点目标入组 131 人开始时间: 2021年1月12日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
131

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
Female

入选标准

  • Women who experience mild to moderate menstruating pain
  • - Aged 18-50 years old
  • - Otherwise healthy
  • - Able to provide informed consent
  • - Regular menstrual cycle (28 days ± 7 days) and period

排除标准

  • - Secondary cause for dysmenorrhea (i.e. endometriosis, adenomyosis, uterine fibroids or infection)
  • - Under or overweight (BMI <18.5 or >35kg/m2)
  • - Any bleeding disorders, recent surgery or concurrent blood thinning treatment
  • - Unstable or serious illness (eg kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, lung conditions, chronic asthma, diagnosed psychological or mood disorder)*
  • - Has or is currently suffering from any form of chronic disease in the past 6 months
  • - Use of any long-term medication that is related to dysmenorrhea or general pain
  • - Malignancy or treatment for malignancy within the previous 2 years
  • - Pregnant or lactating women
  • - Chronic past and/or current alcohol use (>14 alcoholic drinks week)
  • - Chronic smokers
  • - Allergic or hypersensitive to any of the ingredients in active or placebo formula
  • *An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

研究者

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