Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT05728918
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D003139', 'term': 'Common Cold'}], '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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in T cell markers of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Immune analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in B cell markers of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Antibody analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IgA levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Antibody analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IgD levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Antibody analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IgG levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Antibody analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IgE levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Antibody analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IgM levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Cytokine analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IL-1beta levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Cytokine analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IL-4 levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Cytokine analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in IL-6 levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Cytokine analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes inFN-gamma levels of 29 participants will be analyzed between baseline and week 4.'}, {'measure': 'Cytokine analysis', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Changes in TNF-alpha levels of 29 participants will be analyzed between baseline and week 4.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatigue Syndrome, Chronic', 'Cold']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.', 'detailedDescription': 'This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people: a randomized, double-blind, placebo-controlled, and parallel clinical investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are easy to feel fatigued\n* Subjects have poor sleep quality\n\nExclusion Criteria:\n\n* Pregnant women or preparing for pregnancy.\n* Lactating women.\n* Women gave birth 6 months before the study.\n* Poor kindy and livers funcitons\n* Severe cardiovascular or other chronic diseases\n* Alcohol abuser\n* Using immune-associated supplements'}, 'identificationModule': {'nctId': 'NCT05728918', 'briefTitle': 'Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People', 'organization': {'class': 'INDUSTRY', 'fullName': 'Greenyn Biotechnology Co., Ltd.'}, 'officialTitle': 'Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People', 'orgStudyIdInfo': {'id': 'A-111-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placeo group', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Experimental group', 'interventionNames': ['Dietary Supplement: Antrodia cinnamomea mycelia']}], 'interventions': [{'name': 'Antrodia cinnamomea mycelia', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Antrodia cinnamomea mycelia capsule, two capsules/day (600 mg/day) for 3 months', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo capsule, two capsules/day (600 mg/day) for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ming-Shun Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WanFang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Greenyn Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}