Clincosm LogoSign in Get a demo

Rhodiola Rosea for Mental and Physical Fatigue

Sponsor
Government of Alberta (Other)
Overall Status
Unknown status
CT.gov ID
NCT01278992
Collaborator
University of Alberta (Other)
90
Enrollment
1
Location
3
Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Rhodiola rosea
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2011
Anticipated Primary Completion Date :
Apr 1, 2011
Anticipated Study Completion Date :
Apr 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Fatigue [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 [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 [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 [42 days]

    Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors

  4. Adverse Event Monitoring [42 days]

    number of patients with any untoward medical occurance as a measure of safety

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01278992
Other Study ID Numbers:
  • 2006C002P
First Posted:
Jan 19, 2011
Last Update Posted:
Feb 15, 2011
Last Verified:
Feb 1, 2011
Keywords provided by , ,
fatigue
adaptogen
Rhodiola rosea
Additional relevant MeSH terms:
Fatigue

Study Results

No Results Posted as of Feb 15, 2011