Rhodiola Rosea for Mental and Physical Fatigue

This study is enrolling participants by invitation only.
Sponsor:
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
  Purpose

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
Fatigue
Dietary Supplement: Rhodiola rosea
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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.



Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors

  • Adverse Event Monitoring [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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
  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278992

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

No publications provided

Responsible Party: Dr. Susan Lutz, Manager - Functional Foods and Natural Health Products, Government of Alberta
ClinicalTrials.gov Identifier: NCT01278992     History of Changes
Other Study ID Numbers: 2006C002P
Study First Received: January 17, 2011
Last Updated: February 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by Government of Alberta:
fatigue
adaptogen
Rhodiola rosea

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014