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Rhodiola Rosea for Mental and Physical Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
University of Alberta
Information provided by:
Government of Alberta

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fatigue Dietary Supplement: Rhodiola rosea Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Adaptive Capacity [ Time Frame: 42 days ]
    Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors

  4. Adverse Event Monitoring [ Time Frame: 42 days ]
    number of patients with any untoward medical occurance as a measure of safety


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
Government of Alberta
University of Alberta
Investigators
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Principal Investigator: Sunita Vohra, MD FRCPC MSc University of Alberta
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Susan Lutz, Manager - Functional Foods and Natural Health Products, Government of Alberta
ClinicalTrials.gov Identifier: NCT01278992    
Other Study ID Numbers: 2006C002P
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011
Keywords provided by Government of Alberta:
fatigue
adaptogen
Rhodiola rosea
Additional relevant MeSH terms:
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Fatigue