Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT01378702
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-20', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'After 4 weeks treatment with each dose', 'description': 'Week 4 after baseline: evaluation of Iscucin populi strength F and Viscum Mali D3, respectively, compared to placebo. Week 8 after baseline: evaluation of Iscucin populi strength G and Viscum Mali D2, respectively, compared to placebo. Week 12 after baseline: evaluation of Iscucin populi strength H and Viscum mali 2%, respectively, compared to placebo. Week 16 after baseline: final follow up'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6', 'timeFrame': 'After 4 weeks treatment with each dose', 'description': 'see primary outcome measure'}, {'measure': 'Eosinophil counts', 'timeFrame': 'After 4 weeks treatment with each dose', 'description': 'see primary outcome measure'}, {'measure': 'Granulocyte counts', 'timeFrame': 'After 4 weeks treatment with each dose', 'description': 'see primary outcome measure'}, {'measure': 'Lymphocyte counts', 'timeFrame': 'After 4 weeks treatment with each dose', 'description': 'see primary outcome measure'}, {'measure': 'T-cell counts', 'timeFrame': 'After 4 weeks treatment with each dose', 'description': 'see primary outcome measure'}, {'measure': 'General tolerability of the treatment(excellent, good, moderate or bad)', 'timeFrame': 'After 4 weeks treatment with each dose', 'description': 'see primary outcome measure. Toleability will be indicated by the participants on a 4-point rating scale with the items "excellent", "good", "moderate" or "bad", which will be coded by 1, 2, 3 or 4.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mistletoe', 'Anthroposophical medicine'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '22114899', 'type': 'DERIVED', 'citation': 'Huber R, Ludtke H, Wieber J, Beckmann C. Safety and effects of two mistletoe preparations on production of Interleukin-6 and other immune parameters - a placebo controlled clinical trial in healthy subjects. BMC Complement Altern Med. 2011 Nov 24;11:116. doi: 10.1186/1472-6882-11-116.'}], 'seeAlsoLinks': [{'url': 'http://www.uni-zentrum-naturheilkunde.de', 'label': 'Center for Complementary Medicine, University Hospital Freiburg'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to describe safety, tolerability and the course of parameters of the immune system during administration of different doses of two subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta tota) in healthy volunteers, compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years. Healthy volunteers\n\nExclusion Criteria:\n\n* Any disease except hay fever.\n* Smoking.\n* Drug abuse.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01378702', 'briefTitle': 'Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'viscum-1'}, 'secondaryIdInfos': [{'id': '2007-002166-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iscucin populi strength F, G and H', 'description': '1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H.', 'interventionNames': ['Drug: mistletoe preparations']}, {'type': 'EXPERIMENTAL', 'label': 'Viscum Mali e planta tota D3, D2, 2%', 'description': '1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%.', 'interventionNames': ['Drug: mistletoe preparations']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 ampoule two times a week subcutaneously', 'interventionNames': ['Drug: mistletoe preparations']}], 'interventions': [{'name': 'mistletoe preparations', 'type': 'DRUG', 'otherNames': ['1. Mistletoe from the poplar tree', '2. Mistletoe from the apple tree'], 'description': '1 ampoule (1ml) twice per week subcutaneously', 'armGroupLabels': ['Iscucin populi strength F, G and H', 'Placebo', 'Viscum Mali e planta tota D3, D2, 2%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Germany', 'country': 'Germany', 'facility': 'Univerity Medical Center Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Roman Huber, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Roman Huber, Dr', 'oldOrganization': 'University Hospital Freiburg'}}}}