Rhodiola Rosea for Mental and Physical Fatigue

Fatigue Clinical Trial

Official title:

A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01278992
• Other study ID #: 2006C002P
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: January 17, 2011
• Last updated: February 14, 2011
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: February 2011
• Source: Government of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatigue

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Government of Alberta	University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	42 days	No
Secondary	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	42 days	No
Secondary	Individualized Outcomes	Measure Yourself Medical Outcomes Profiles to measure change in items of importance to the participant, as identified by the participant.	42 days	No
Secondary	Adaptive Capacity	Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors	42 days	No
Secondary	Adverse Event Monitoring	number of patients with any untoward medical occurance as a measure of safety	42 days	Yes