Rhodiola Rosea for Mental and Physical Fatigue

Study Overview
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Brief Summary
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The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.

Official Title
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A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: Rhodiola rosea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Rhodiola rosea|1 capsule = 182 mg Rhodiola rosea extract standardized to 2.8% total rosavins. Take 2 capsules at start of wakeful period each day. Participants will self-determine need for second dose, of 1 capsule, within 4 hours of the initial dose.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | 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. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | The health-related quality of life, RAND-36 will also assess physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social function, emotional well-being,and general health perceptions | 42 days | 
| Individualized Outcomes | Measure Yourself Medical Outcomes Profiles to measure change in items of importance to the participant, as identified by the participant. | 42 days | 
| Adaptive Capacity | Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors | 42 days | 
| Adverse Event Monitoring | number of patients with any untoward medical occurance as a measure of safety | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, adaptogen, Rhodiola rosea