Rhodiola Rosea for Mental and Physical Fatigue
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|ClinicalTrials.gov Identifier: NCT01278992|
Recruitment Status : Unknown
Verified February 2011 by Government of Alberta.
Recruitment status was: Enrolling by invitation
First Posted : January 19, 2011
Last Update Posted : February 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fatigue||Dietary Supplement: Rhodiola rosea||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||April 2011|
- 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.Other Name: University of Alberta Lot Number 120910
- Fatigue [ Time Frame: 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.
- Health-related quality of life [ Time Frame: 42 days ]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 ]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 ]Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors
- Adverse Event Monitoring [ Time Frame: 42 days ]number of patients with any untoward medical occurance as a measure of safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278992
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2E1|
|Principal Investigator:||Sunita Vohra, MD FRCPC MSc||University of Alberta|