The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students: A Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from Baseline Fatigue Level to Four Weeks
研究概览
简要总结
The goal of this randomized controlled trial is to determine the effect of traditional herbal supplements on general fatigue and negative emotions in generally healthy graduate students. The main questions it aims to answer are:
• Whether the traditional herbal supplements can ameliorate fatigue and negative emotions of young adults
详细描述
Participants will:
- Take oral herbal supplements or placebo as randomized for four weeks
- Be evaluated for the fatigue, anxiety, and depression levels at baseline and four weeks after the intervention
- Record sleep variables each day for five weeks
Researchers will compare the intervention group (receiving herbal supplements) with the placebo group (receiving placebo) to see if oral herbal supplements have effects on the outcomes and to examine the anti-fatigue effect two weeks after intervention.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scoring at least 4 points on the dichotomous Chalder's Fatigue Scale at baseline
- •Working on at least one ongoing research project and expecting to continue working for at least one month
排除标准
- •Taking medications as:
- •Antidepressants
- •Anxiolytics
- •CNS stimulants
- •Immunosuppressants
- •With underlying diseases as:
- •Diabetes mellitus
- •Hematologic diseases
- •Other major diseases as defined my MOHW of Taiwan
结局指标
主要结局
Change from Baseline Fatigue Level to Four Weeks
时间窗: At week one (baseline) and week five (four weeks after the intervention)
Measured by validated Chinese version of Chalder's Fatigue Scale, the score of which ranges from 0-33, with the higher representing a higher fatigue level (i.e. a worse outcome).
次要结局
- Change from Baseline Sleep Quality to Four Weeks(At week one and week five)
- Change from Baseline Fatigue At Each Week up to Six Weeks(Each week since week one until week seven)
- Sleep Variables (Efficiency, Length, Midsleep time)(Each day from week one through week five)
- Change from Baseline Negative Emotion Scores to Four Weeks(At week one and week five)
- Change from Baseline Negative Emotion States to Four Weeks(At week one and week five)
研究者
Hsin-Jen Chen
Associate Professor
National Yang Ming Chiao Tung University