Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-31 @ 3:59 AM
Study NCT ID:
NCT01106703
Status:
COMPLETED
Last Update Posted:
2010-07-27
First Post:
2010-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562694', 'term': 'Epilepsy, Idiopathic Generalized'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-23', 'studyFirstSubmitDate': '2010-04-19', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum total IgE level', 'timeFrame': '8weeks'}], 'secondaryOutcomes': [{'measure': 'serum level of allergy-related factors, such as eosinophilic cation protein(ECP), eotaxin, thymus, and activation-regulated chemokine (TARC), IL-4, IL-5, and IL-13, skin test(atopy score), and adverse reactions', 'timeFrame': '8weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atopy, IgE'], 'conditions': ['Asymptomatic Subjects With Atopy and Elevated Serum IgE']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects who have atopy but no allergy-related symptoms\n* subjects with total IgE levels of 300IU/ml or more\n* acquisition of written informed consent prior to commencement of study\n* no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators\n\nExclusion Criteria:\n\n* individuals with normal levels of total serum IgE\n* ue of one or more allergic drugs\n* serious clinical conditions (such as malignancies, severe cardiovascular disease etc.)\n* serious mental disorder\n* pregnant woman or woman of childbearing potential within 3 months\n* subjects who participated in other clinical trials in the past 6months\n* individuals who have a plan to participate in another clinical trials during this trial\n* subjects with a history of kiwi allergy\n* subjects whose conditions are inappropriate by investigators'}, 'identificationModule': {'nctId': 'NCT01106703', 'briefTitle': 'The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study', 'orgStudyIdInfo': {'id': 'A060655'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PG102 group', 'interventionNames': ['Dietary Supplement: PG102, a water soluble extract from Actinidia arguta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'PG102, a water soluble extract from Actinidia arguta', 'type': 'DIETARY_SUPPLEMENT', 'description': 'PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks', 'armGroupLabels': ['PG102 group']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soeul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Up Min, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Seoul National University Hospital', 'oldOrganization': 'Seoul National University Hospital'}}}}