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

January 17, 2011
February 14, 2011
January 2011
April 2011   (final data collection date for primary outcome measure)
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.

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.

Complete list of historical versions of study NCT01278992 on ClinicalTrials.gov Archive Site
  • 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
  • Health-related quality of life [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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 ]
    any untoward medical occurance
Not Provided
Not Provided
 
Rhodiola Rosea for Mental and Physical Fatigue
A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses

The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Fatigue
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
90
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
19 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01278992
2006C002P
Yes
Dr. Susan Lutz, Manager - Functional Foods and Natural Health Products, Government of Alberta
Government of Alberta
University of Alberta
Principal Investigator: Sunita Vohra, MD FRCPC MSc University of Alberta
Government of Alberta
February 2011

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