Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT01689467
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2012-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2014-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-21', 'studyFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in lactate', 'timeFrame': '12 weeks', 'description': 'Lactate was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in ammonia', 'timeFrame': '12 weeks', 'description': 'Ammonia was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in inorganic phosphorus', 'timeFrame': '12 weeks', 'description': 'Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in creatine kinase', 'timeFrame': '12 weeks', 'description': 'Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in Lactage dehydrogenase(LDH)', 'timeFrame': '12 weeks', 'description': 'Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).'}], 'secondaryOutcomes': [{'measure': 'Changes in Multidimensional Fatigue Scale(MFS)', 'timeFrame': '12 weeks', 'description': 'Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week).'}, {'measure': 'Changes in 36-Item Short-Form Health Survey(SF-36)', 'timeFrame': '12 weeks', 'description': '36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Fatigue Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue recovery after exercise. The investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females 19-60 years old\n* Hemoglobin concentration between 13 and 14 g/dL(men), 12 and 13 g/dL(women)\n* Able to give informed consent\n\nExclusion Criteria:\n\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* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study\n* Pregnant or lactating women etc."}, 'identificationModule': {'nctId': 'NCT01689467', 'briefTitle': 'Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'orgStudyIdInfo': {'id': 'KD-FR-FVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fermented Velvet Antler extract', 'interventionNames': ['Dietary Supplement: Fermented Velvet Antler extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Fermented Velvet Antler extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fermented Velvet Antler extract (1g/day)', 'armGroupLabels': ['Fermented Velvet Antler extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (1g/day)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560-822', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Clinical Trial Center for Functional Foods; Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}