Rhodiola Rosea for Mental and Physical Fatigue
This study is enrolling participants by invitation only.
Sponsor:
Government of Alberta
Collaborator:
University of Alberta
Information provided by:
Government of Alberta
ClinicalTrials.gov Identifier:
NCT01278992
First received: January 17, 2011
Last updated: February 14, 2011
Last verified: February 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 17, 2011 | ||||
| Last Updated Date | February 14, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01278992 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rhodiola Rosea for Mental and Physical Fatigue | ||||
| Official Title ICMJE | A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses | ||||
| Brief Summary | The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Fatigue | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Estimated Completion Date | April 2011 | ||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01278992 | ||||
| Other Study ID Numbers ICMJE | 2006C002P | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Susan Lutz, Manager - Functional Foods and Natural Health Products, Government of Alberta | ||||
| Study Sponsor ICMJE | Government of Alberta | ||||
| Collaborators ICMJE | University of Alberta | ||||
| Investigators ICMJE |
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| Information Provided By | Government of Alberta | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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