Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-25 @ 3:26 PM
Study NCT ID:
NCT01278992
Status:
UNKNOWN
Last Update Posted:
2011-02-15
First Post:
2011-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhodiola Rosea for Mental and Physical Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-14', 'studyFirstSubmitDate': '2011-01-17', 'studyFirstSubmitQcDate': '2011-01-17', 'lastUpdatePostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '42 days', 'description': 'A vitality subscale of the generic health-related quality of life instrument, RAND-36, will be employed to assess fatigue.\n\nA Visual Analogue Scale for Fatigue (VAS-F) will be concurrently administered to assess fatigue and compare to the RAND-36 fatigue assessment.'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '42 days', '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'}, {'measure': 'Individualized Outcomes', 'timeFrame': '42 days', 'description': 'Measure Yourself Medical Outcomes Profiles to measure change in items of importance to the participant, as identified by the participant.'}, {'measure': 'Adaptive Capacity', 'timeFrame': '42 days', 'description': "Adaptive Capacity Index - 21 item questionnaire to measure a subject's ability to adapt to stressors"}, {'measure': 'Adverse Event Monitoring', 'timeFrame': '42 days', 'description': 'number of patients with any untoward medical occurance as a measure of safety'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fatigue', 'adaptogen', 'Rhodiola rosea'], 'conditions': ['Fatigue']}, 'referencesModule': {'references': [{'pmid': '25268730', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fourth year nursing students enrolled in NURS 495 (Nursing Practice)\n* Participating in permanent overnight (between 11 pm and 7 am) or rotating shift work\n* otherwise healthy\n* consent to participate in the study\n\nExclusion Criteria:\n\n* nurses aged 18 years or younger\n* breastfeeding or pregnant women, as confirmed by a blood test\n* female participants with child bearing potential not practicing a form of birth control throughout the trial\n* presence of a primary medical condition associated with fatigue (e.g. cardiac, gastrointestinal, respiratory, renal, rheumatologic, or oncologic disease)\n* presence of schizophrenia, bipolar disorder, dementia, eating disorders, insomnia or substance abuse\n* presence of diabetes\n* concurrent utilization of hypoglycaemic or agents for raising or lowering blood pressure\n* known allergy or hypersensitivity to Rhodiola rosea or Sedum family extracts or pollen\n* know allergy to microcrystalline cellulose or silicone dioxide\n* concurrent utilization of stimulant drug such as methylphenidate (Ritalin), amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn) and pemoline (Cylert)\n* concurrent utilization of other rhodiola or ginseng products (both fall in the same therapeutic category known as an "adaptogen")\n* any significant medical condition\n* any neurological or mental health condition\n* taking medication that has central nervous system effects\n* aged 55 years or older\n* low blood pressure or history of significant dizziness'}, 'identificationModule': {'nctId': 'NCT01278992', 'briefTitle': 'Rhodiola Rosea for Mental and Physical Fatigue', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Government of Alberta'}, 'officialTitle': 'A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses', 'orgStudyIdInfo': {'id': '2006C002P'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rhodiola rosea', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['University of Alberta Lot Number 120910'], '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2E1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Sunita Vohra, MD FRCPC MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government of Alberta', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Susan Lutz, Manager - Functional Foods and Natural Health Products', 'oldOrganization': 'Government of Alberta'}}}}