临床试验/NCT02019368

NCT02019368已完成不适用

A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Antioxidant Effect of Aged Garlic Extract in Heavy Smokers

Hiroshima University2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2013年11月最近更新: 2015年8月19日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hiroshima University
入组人数: 60
试验地点: 2
主要终点: Urinary 8-hydroxydeoxyguanosine (8-OHdG)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Prevention
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 40 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)

排除标准

•Under medication for chronic disease
•Garlic allergy
•Engaging in vigorous exercise
•Taking drugs or functional food that may possess antioxidant property
•Participation in any clinical trial within 90 days of the commencement of the trial
•Renal or hepatic dysfunction
•Heart disease

结局指标

主要结局

Urinary 8-hydroxydeoxyguanosine (8-OHdG)

时间窗: Every 4 weeks (Overall 12 weeks)

次要结局

High sensitive CRP(Every 4 weeks (Overall 12 weeks))
Blood pressure(Every 4 weeks (Overall 12 weeks))
Indices of the second derivative of photoplethysmogram (SDPTG)(Every 4 weeks (Overall 12 weeks))

研究者

发起方

Hiroshima University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Fumiko Higashikawa

Associate Professor

Hiroshima University

研究点 (2)

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