Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
Study NCT ID:
NCT04319692
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2020-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2020-03-21', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue severity scale', 'timeFrame': '8 weeks', 'description': 'Fatigue severity scale, minimum\\~maximum values (1\\~7), higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Lactate level', 'timeFrame': '8 weeks', 'description': 'Lactate level (mg/dL)'}, {'measure': 'Creatinine kinase level', 'timeFrame': '8 weeks', 'description': 'Creatinine kinase level (IU/L)'}, {'measure': 'Urinary malondialdehyde level', 'timeFrame': '8 weeks', 'description': 'Urinary malondialdehyde level (mmol/mg Cr)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatigue']}, 'referencesModule': {'references': [{'pmid': '36438753', 'type': 'DERIVED', 'citation': 'Choi JI, Lee YL, Lee SY. Efficacy and safety of fermented Prunus mume vinegar on fatigue improvement in adults with unexplained fatigue: A randomized controlled trial. Front Nutr. 2022 Nov 9;9:990418. doi: 10.3389/fnut.2022.990418. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Prunus Mume Vinega on Improvement of Fatigue in adults for 8 weeks.', 'detailedDescription': 'Previous studies have indicated that Fermented Prunus Mume Vinega may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of tFermented Prunus Mume Vinega on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine fatigue severity scale, lactate, creatinine kinase, urinary malondialdehyde at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Fermented Prunus Mume Vinega or a placebo each day for 8 weeks;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who complain of fatigue for more than 1 month\n* Fatigue Severity Scale 3 points or more\n\nExclusion Criteria:\n\n* chronic hepatitis B or C infection\n* being treated for hypothyroidism or hyperthyroidism\n* more than twice the normal upper limit of Creatinine\n* Liver enzyme value is more than twice the normal upper limit\n* Uncontrolled diabetes (over 160 mg / dl of fasting blood sugar)\n* Uncontrolled hypertension (more than 160/100 mmHg, measured after 10 minutes of stability in subjects) or those with heart disease, such as angina or myocardial infarction\n* taking medications that affect fatigue within the past 1 month (psychiatric drugs such as Chinese medicine, soy drugs, depression, beta-blockers, steroids, hormones, etc.). However, intermittent medication due to sleep disorders is excluded.\n* a history of gastrointestinal resection or complain of severe gastrointestinal symptoms such as heartburn and indigestion\n* already have participated in or plan to participate in another drug clinical trial\n* Alcohol abusers\n* pregnant, lactating or have a pregnancy plan during the clinical trial period\n* allergic reactions to Fermented Prunus Mume Vinegar\n* A person deemed inappropriate by the researcher for other reasons'}, 'identificationModule': {'nctId': 'NCT04319692', 'briefTitle': 'Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '02-2018-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fermented Prunus Mume Vinegar group', 'description': 'This group takes Fermented Prunus Mume Vinegar for 8 weeks.', 'interventionNames': ['Dietary Supplement: Fermented Prunus Mume Vinegar group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'This group takes placebo for 8 weeks.', 'interventionNames': ['Dietary Supplement: Placebo group']}], 'interventions': [{'name': 'Fermented Prunus Mume Vinegar group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This group takes Fermented Prunus Mume Vinegar for 8 weeks', 'armGroupLabels': ['Fermented Prunus Mume Vinegar group']}, {'name': 'Placebo group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This group takes placebo for 8 weeks.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeungsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Sang Yeoup Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Yeoup Lee', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}