Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Fatigue severity scale
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Prunus Mume Vinega on Improvement of Fatigue in adults for 8 weeks.
详细描述
Previous studies have indicated that Fermented Prunus Mume Vinega may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of tFermented Prunus Mume Vinega on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine fatigue severity scale, lactate, creatinine kinase, urinary malondialdehyde at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Fermented Prunus Mume Vinega or a placebo each day for 8 weeks;
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who complain of fatigue for more than 1 month
- •Fatigue Severity Scale 3 points or more
排除标准
- •chronic hepatitis B or C infection
- •being treated for hypothyroidism or hyperthyroidism
- •more than twice the normal upper limit of Creatinine
- •Liver enzyme value is more than twice the normal upper limit
- •Uncontrolled diabetes (over 160 mg / dl of fasting blood sugar)
- •Uncontrolled hypertension (more than 160/100 mmHg, measured after 10 minutes of stability in subjects) or those with heart disease, such as angina or myocardial infarction
- •taking medications that affect fatigue within the past 1 month (psychiatric drugs such as Chinese medicine, soy drugs, depression, beta-blockers, steroids, hormones, etc.). However, intermittent medication due to sleep disorders is excluded.
- •a history of gastrointestinal resection or complain of severe gastrointestinal symptoms such as heartburn and indigestion
- •already have participated in or plan to participate in another drug clinical trial
- •Alcohol abusers
- •pregnant, lactating or have a pregnancy plan during the clinical trial period
- •allergic reactions to Fermented Prunus Mume Vinegar
- •A person deemed inappropriate by the researcher for other reasons
结局指标
主要结局
Fatigue severity scale
时间窗: 8 weeks
Fatigue severity scale, minimum\~maximum values (1\~7), higher scores mean a worse outcome.
次要结局
- Creatinine kinase level(8 weeks)
- Lactate level(8 weeks)
- Urinary malondialdehyde level(8 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital