Rhodiola Rosea for Mental and Physical Fatigue
|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|