FatiguePhase 2NCT01278992
Rhodiola Rosea for Mental and Physical Fatigue
A Phase 2 study testing Rhodiola rosea in people with Fatigue, run by Government of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Rhodiola rosea
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fatigue
- Being tested
- Rhodiola rosea
- Keywords
- fatigue, adaptogen, Rhodiola rosea
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhodiola roseaDietary supplement
Also called University of Alberta Lot Number 120910
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days
Secondary outcomes (4)
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
Measured: 42 days
Individualized Outcomes
Measure Yourself Medical Outcomes Profiles to measure change in items of importance to the participant, as identified by the participant.
Measured: 42 days
Adaptive Capacity
Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors
Measured: 42 days
Adverse Event Monitoring
number of patients with any untoward medical occurance as a measure of safety
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government of Alberta
- Sponsor type
- Other government
- Collaborators
- University of Alberta
- Investigators
- Sunita Vohra, MD FRCPC MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278992
- Sponsor's protocol ID
- 2006C002P
- Status last verified
- Feb 2011
- First submitted
- 17 Jan 2011
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25268730
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses
- ClinicalTrials.gov ID
- NCT01278992
- Acronym / sponsor ID
- 2006C002P
- Conditions
- Fatigue
- Keywords
- fatigue, adaptogen, Rhodiola rosea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Government of AlbertaOther government
- Collaborators
- University of Alberta
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhodiola roseaAlso: University of Alberta Lot Number 1209101 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. | Dietary supplement | – |
Primary outcome
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.
4 secondary outcomes
Health-related quality of life
Time frame: 42 days
Individualized Outcomes
Time frame: 42 days
Adaptive Capacity
Time frame: 42 days
Adverse Event Monitoring
Time frame: 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
- Derived from this study: PubMed 25268730Punja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunita Vohra, MD FRCPC MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rhodiola rosea in people with Fatigue, run by Government of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2011.