Rhodiola Rosea for Mental and Physical Fatigue
The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses|
- Fatigue [ Time Frame: 42 days ] [ Designated as safety issue: No ]
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.
- Health-related quality of life [ Time Frame: 42 days ] [ Designated as safety issue: No ]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
- Individualized Outcomes [ Time Frame: 42 days ] [ Designated as safety issue: No ]Measure Yourself Medical Outcomes Profiles to measure change in items of importance to the participant, as identified by the participant.
- Adaptive Capacity [ Time Frame: 42 days ] [ Designated as safety issue: No ]Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors
- Adverse Event Monitoring [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]number of patients with any untoward medical occurance as a measure of safety
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Dietary Supplement: Rhodiola rosea
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278992
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2E1|
|Principal Investigator:||Sunita Vohra, MD FRCPC MSc||University of Alberta|