ACTRN12619001368123已完成3 期
The effect of Palmitoylethanolamide (PEA) supplementation on the symptoms of allergic rhinitis - A double-blind placebo controlled trial.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
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 o limit（—）
- 性别
- All
入选标准
- •Male and females over 18 years old
- •Reporting seasonal allergic rhinitis
- •Generally healthy
- •Able to provide informed consent
- •Females using a prescribed form of birth control birth control, abstinent or post-menopausal
- •Agree not to change current diet/exercise or not to use other supplements/products for allergy
- •relief other than the test product during study period.
- •A score of 3 or more on at least 4 of the 7 baseline days for the 24 hour score on the rTNSS #
- •# Participants will undertake 7 days of rTNSS and continue to take supplement once they fulfil the
- •rTNSS score requirement.
排除标准
- •Unstable or serious illness (e.g. MS, kidney, liver, GIT, heart conditions, diabetes, thyroid
- •gland function Malignancy) including mental/mood disorders (e.g. depression and bipolar)*
- •Malignancy or treatment for malignancy within the previous 2 years
- •Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other
- •anticoagulation therapy
- •Active smokers, nicotine, alcohol, drug abuse
- •Chronic past and/or current alcohol use (consumption of more than 14 standard alcoholic drinks per week)
- •Allergic to any of the ingredients in active or placebo formula
- •Pregnant or lactating woman §
- •Any condition which in the opinion of the investigator makes the participant unsuitable for
- •* 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.
- •§ Participants who have any reason to feel there is any possibility they are pregnant will be offered a
- •pregnancy test to undertake before continuing.
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