NCT01278992Unknown2 期
A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fourth year nursing students enrolled in NURS 495 (Nursing Practice)
- •Participating in permanent overnight (between 11 pm and 7 am) or rotating shift work
- •otherwise healthy
- •consent to participate in the study
排除标准
- •nurses aged 18 years or younger
- •breastfeeding or pregnant women, as confirmed by a blood test
- •female participants with child bearing potential not practicing a form of birth control throughout the trial
- •presence of a primary medical condition associated with fatigue (e.g. cardiac, gastrointestinal, respiratory, renal, rheumatologic, or oncologic disease)
- •presence of schizophrenia, bipolar disorder, dementia, eating disorders, insomnia or substance abuse
- •presence of diabetes
- •concurrent utilization of hypoglycaemic or agents for raising or lowering blood pressure
- •known allergy or hypersensitivity to Rhodiola rosea or Sedum family extracts or pollen
- •know allergy to microcrystalline cellulose or silicone dioxide
- •concurrent utilization of stimulant drug such as methylphenidate (Ritalin), amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn) and pemoline (Cylert)
- •concurrent utilization of other rhodiola or ginseng products (both fall in the same therapeutic category known as an "adaptogen")
- •any significant medical condition
- •any neurological or mental health condition
- •taking medication that has central nervous system effects
- •aged 55 years or older
- •low blood pressure or history of significant dizziness
结局指标
主要结局
Fatigue
时间窗: 42 days
A vitality subscale of the generic health-related quality of life instrument, RAND-36, will be employed to assess fatigue. A Visual Analogue Scale for Fatigue (VAS-F) will be concurrently administered to assess fatigue and compare to the RAND-36 fatigue assessment.
次要结局
- Health-related quality of life(42 days)
- Individualized Outcomes(42 days)
- Adaptive Capacity(42 days)
- Adverse Event Monitoring(42 days)
研究者
研究点 (2)
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