search
Back to results

Rhodiola Rosea for Mental and Physical Fatigue

Primary Purpose

Fatigue

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Rhodiola rosea
Sponsored by
Government of Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fatigue focused on measuring fatigue, adaptogen, Rhodiola rosea

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alberta

Outcomes

Primary Outcome Measures

Fatigue
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
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
Measure Yourself Medical Outcomes Profiles to measure change in items of importance to the participant, as identified by the participant.
Adaptive Capacity
Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors
Adverse Event Monitoring
number of patients with any untoward medical occurance as a measure of safety

Full Information

First Posted
January 17, 2011
Last Updated
February 14, 2011
Sponsor
Government of Alberta
Collaborators
University of Alberta
search

1. Study Identification

Unique Protocol Identification Number
NCT01278992
Brief Title
Rhodiola Rosea for Mental and Physical Fatigue
Official Title
A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Government of Alberta
Collaborators
University of Alberta

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
fatigue, adaptogen, Rhodiola rosea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Rhodiola rosea
Other Intervention Name(s)
University of Alberta Lot Number 120910
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
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
Time Frame
42 days
Title
Individualized Outcomes
Description
Measure Yourself Medical Outcomes Profiles to measure change in items of importance to the participant, as identified by the participant.
Time Frame
42 days
Title
Adaptive Capacity
Description
Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors
Time Frame
42 days
Title
Adverse Event Monitoring
Description
number of patients with any untoward medical occurance as a measure of safety
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Vohra, MD FRCPC MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25268730
Citation
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.
Results Reference
derived

Learn more about this trial

Rhodiola Rosea for Mental and Physical Fatigue

We'll reach out to this number within 24 hrs