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Rhodiola Rosea for Mental and Physical Fatigue

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Government of Alberta.
Recruitment status was:  Enrolling by invitation
University of Alberta
Information provided by:
Government of Alberta Identifier:
First received: January 17, 2011
Last updated: February 14, 2011
Last verified: February 2011
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 Intervention Phase
Dietary Supplement: Rhodiola rosea
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses

Resource links provided by NLM:

Further study details as provided by Government of Alberta:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 90
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)
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

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

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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Please refer to this study by its identifier: NCT01278992

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
Government of Alberta
University of Alberta
Principal Investigator: Sunita Vohra, MD FRCPC MSc University of Alberta
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Susan Lutz, Manager - Functional Foods and Natural Health Products, Government of Alberta Identifier: NCT01278992     History of Changes
Other Study ID Numbers: 2006C002P
Study First Received: January 17, 2011
Last Updated: February 14, 2011

Keywords provided by Government of Alberta:
Rhodiola rosea

Additional relevant MeSH terms:
Signs and Symptoms processed this record on April 26, 2017