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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
Sponsor:
Collaborator:
University of Alberta
Information provided by:
Government of Alberta

Tracking Information
First Submitted Date  ICMJE January 17, 2011
First Posted Date  ICMJE January 19, 2011
Last Update Posted Date February 15, 2011
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2011)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2011)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2011)
  • Health-related quality of life [ Time Frame: 42 days ]
    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 ]
    any untoward medical occurance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Arms  ICMJE Not Provided
Publications * Punja S, Shamseer L, Olson K, Vohra S. Rhodiola rosea for mental and physical fatigue in nursing students: a randomized controlled trial. PLoS One. 2014 Sep 30;9(9):e108416. doi: 10.1371/journal.pone.0108416. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 17, 2011)		 90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2011
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01278992
Other Study ID Numbers  ICMJE 2006C002P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Susan Lutz, Manager - Functional Foods and Natural Health Products, Government of Alberta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Government of Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Alberta
Investigators  ICMJE
Principal Investigator: Sunita Vohra, MD FRCPC MSc University of Alberta
PRS Account Government of Alberta
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP