Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 1:44 PM
Study NCT ID:
NCT01006460
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2009-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With Arctic Root Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713177', 'term': 'Siberian ginseng root'}, {'id': 'C011105', 'term': 'schizandrin'}, {'id': 'C000713447', 'term': 'Asian ginseng'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-26', 'studyFirstSubmitDate': '2009-11-01', 'studyFirstSubmitQcDate': '2009-11-01', 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention', 'timeFrame': 'Over a period of 28 days of treatment'}], 'secondaryOutcomes': [{'measure': 'Depression parameters: changes in depressive state as measured by the using Hamilton Depression Rating Scale (HAM-D) and Bechs Depression Inventory (BDI).', 'timeFrame': 'over a period of 28 days of treatment'}, {'measure': 'Quality of Life parameters: changes in quality of life as measured by the SF-36 scale, Danish Stress Profile (SP) test and questions regarding various aspects of well-being as formulated in a non-validated VAS scale', 'timeFrame': 'Over a period of 28 days of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quality of life and subjective well-being in middle aged women'], 'conditions': ['Depression', 'Stress']}, 'descriptionModule': {'briefSummary': 'This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the study in order to evaluate its effect in comparison to the others.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy females, over 40 years of age, who have stated that they for a longer period of time have felt stressed due to demanding daily activities at work and/or at home.\n\nExclusion Criteria:\n\n* suffering from any known medical disease, e.g. cardiovascular, joint, and liver or kidney diseases, cancer, or psychiatric disease.\n* with a psychiatric diagnose, using narcotics or suffering from HIV.\n* with known allergy to any of the study medications.\n* misusing euphorizing or pain killing drugs\n* having used any adaptogenic product the last 2 months.\n* having used cortisol or any other corticosteroid products the last 6 months\n* being pregnant or breast-feeding\n* which at the first interview are judged to be not cooperative or not to be able to finalize the study'}, 'identificationModule': {'nctId': 'NCT01006460', 'briefTitle': 'A Study With Arctic Root Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'A Randomized, Placebo Controlled, Parallel, Double Blinded Trial With Rhodiola Rosea Extract SHR-5 (Arctic Root) Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed', 'orgStudyIdInfo': {'id': 'SHR5/DK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapt 232', 'interventionNames': ['Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis']}, {'type': 'EXPERIMENTAL', 'label': 'Arctic root group', 'interventionNames': ['Drug: Rhodiola rosea, L']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ginseng group', 'interventionNames': ['Drug: Panax ginseng']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo - dark brown sugar']}], 'interventions': [{'name': 'Rhodiola rosea, L', 'type': 'DRUG', 'description': '3 Capsules twice a day', 'armGroupLabels': ['Arctic root group']}, {'name': 'Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis', 'type': 'DRUG', 'description': '3 capsules twice a day', 'armGroupLabels': ['Adapt 232']}, {'name': 'Panax ginseng', 'type': 'DRUG', 'description': '3 capsules twice a day', 'armGroupLabels': ['Ginseng group']}, {'name': 'Placebo - dark brown sugar', 'type': 'DRUG', 'description': '3 capsules twice a day', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Clinical Biochemistry, Frederikbergs Hospital', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Kaj Winther, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Biochemistry department, Frederiksberg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frederiksberg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kaj Winther Hansen', 'oldOrganization': 'Frederiksbegg University Hospital'}}}}