Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT01278992
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT01278992
Study Brief:
Protocol Section:
NCT01278992