Rhodiola Rosea for Mental and Physical Fatigue

NCT ID: NCT01278992

Last Updated: 2011-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

University of Alberta Lot Number 120910

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: collaborator

Government of Alberta

OTHER_GOV

Sponsor Role: lead

Responsible Party

Government of Alberta

Principal Investigators

Sunita Vohra, MD FRCPC MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25268730 (View on PubMed)

Other Identifiers

2006C002P

Identifier Type: -

Identifier Source: org_study_id