Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 8:35 PM
Study NCT ID:
NCT03277833
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2016-05-13', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score of State&Trait version of STAI', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Score of State\\&Trait version of STAI was measured in study screening and visit 3(8 week).'}], 'secondaryOutcomes': [{'measure': 'Change of Blood Norepinephrine Level', 'timeFrame': 'Baseline and 8 week', 'description': 'Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).'}, {'measure': 'Change of Blood Cortisol Level', 'timeFrame': 'Baseline and 8 week', 'description': 'Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week).'}, {'measure': 'Change in score of Beck Anxiety Inventory', 'timeFrame': 'Baseline and 8 week', 'description': 'Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Stress-Induced Strain']}, 'descriptionModule': {'briefSummary': 'The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. The investigators measured decrement of body fat parameters, State\\&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety Inventory(HAM-A), and monitored their blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Age 20-65 years with chronic stress( S-STAI score 40\\~60)\n\nExclusion Criteria:\n\n* excessive physically chronic fatigue\n* Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior to the study\n* Cardiovascular disease\n* Allergic or hypersensitive to any of the ingredients in the test products\n* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery\n* Participation in any other clinical trials within past 2 months\n* Renal disease\n* Abnormal hepatic function\n* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study\n* History of alcohol or substance abuse\n* Pregnancy or lacting women etc."}, 'identificationModule': {'nctId': 'NCT03277833', 'briefTitle': 'Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain', 'orgStudyIdInfo': {'id': 'CBU-STR-DOLWOE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gynostemma Pentaphyllum(Dungkulcha) Extract', 'description': 'Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)', 'interventionNames': ['Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design', 'armGroupLabels': ['Gynostemma Pentaphyllum(Dungkulcha) Extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo, parallel design', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}