Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT05878834
Status:
UNKNOWN
Last Update Posted:
2023-05-30
First Post:
2023-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced expiratory volume in 1 second/Forced vital capacity', 'timeFrame': '12 weeks', 'description': 'Forced expiratory volume in 1 second/Forced vital capacity in % (high value means better pulmonary function)'}], 'secondaryOutcomes': [{'measure': 'Modified Medical Research Council Dyspnea Score', 'timeFrame': '12 weeks', 'description': 'Modified Medical Research Council Dyspnea Score shows in dyspnea score (score 0 to 4 means low dyspnea to high severity).'}, {'measure': 'Breathlessness, Cough, and Sputum Scale', 'timeFrame': '12 weeks', 'description': 'Breathlessness, Cough, and Sputum Scale shows in severity scale (scale 0 to 4 means no symptom to high severity)'}, {'measure': '6-minute walk test', 'timeFrame': '12 weeks', 'description': '6-minute walk test in walking distance in 6 minutes (meters) (high value means better performance)'}, {'measure': 'Chronic obstructive pulmonary disease assessment test', 'timeFrame': '12 weeks', 'description': 'Chronic obstructive pulmonary disease assessment test in scale 0 to 5 (high value means better quality of life)'}, {'measure': 'Tumor necrosis factor alpha', 'timeFrame': '12 weeks', 'description': 'Tumor necrosis factor alpha is a pro-inflammatory cytokine (picogram/ml) (high value means high risk of inflammation)'}, {'measure': 'Interleukin-6', 'timeFrame': '12 weeks', 'description': 'Interleukin-6 is a biomarker of inflammation (picogram/ml) (high value means high risk of inflammation)'}, {'measure': 'C-reactive protein', 'timeFrame': '12 weeks', 'description': 'C-reactive protein refers to inflammation (mg/ml) (high value means high risk of inflammation)'}, {'measure': 'Aspartate transaminase', 'timeFrame': '12 weeks', 'description': 'Aspartate transaminase refers to liver function (U/L)'}, {'measure': 'Alanine transaminase', 'timeFrame': '12 weeks', 'description': 'Alanine transaminase refers to liver function (U/L)'}, {'measure': 'Alkaline phosphatase', 'timeFrame': '12 weeks', 'description': 'Alkaline phosphatase refers to liver function (U/L)'}, {'measure': 'Creatinine', 'timeFrame': '12 weeks', 'description': 'Creatinine refers to renal function (mg/dl)'}, {'measure': 'Blood urea nitrogen', 'timeFrame': '12 weeks', 'description': 'Blood urea nitrogen refers to renal function (mg/dl)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary', 'beta-glucan'], 'conditions': ['Chronic Obstructive Pulmonary Disease Patients']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.', 'detailedDescription': 'There are 72 patients in this study. They are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. The supplement will be taken 1 capsule/day for 12 weeks. Forced expiratory volume in 1 second/Forced vital capacity, Modified Medical Research Council Dyspnea Score, Breathlessness, Cough, and Sputum Scale, 6 Minute Walk Test, Diffusing capacity for carbon monoxide, Tumor necrosis factor alpha, Interleukin-6, C-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18 years\n* Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine more than 70%\n* No exacerbation and uncontrolled disease\n* 10 pack-years smoking history 10 pack-years but stop smoking more than 1 years\n* Willing to participate in this study\n\nExclusion Criteria:\n\n* Respiratory infection in 4 weeks\n* Lung cancer\n* Liver disease or kidney disease\n* Lung surgery history\n* Take kung supplement in 2 weeks\n* Take warfarin, clopidogrel, aspirin, or digoxin\n* Allergic to beta-glucan, broccoli, or quercetin\n* Cannot use Spirometry\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT05878834', 'briefTitle': 'Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients', 'orgStudyIdInfo': {'id': 'Oh87/65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta-glucan supplement group', 'description': 'Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg.', 'interventionNames': ['Dietary Supplement: Beta-glucan supplement group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo capsule is empty capsule.', 'interventionNames': ['Dietary Supplement: Placebo group']}], 'interventions': [{'name': 'Beta-glucan supplement group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 1 capsule 1 time per day for 12 weeks.', 'armGroupLabels': ['Beta-glucan supplement group']}, {'name': 'Placebo group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 1 capsule 1 time per day for 12 weeks.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pornanong Aramwit, Professor', 'role': 'CONTACT', 'email': 'aramwit@gmail.com', 'phone': '+66899217255'}], 'overallOfficials': [{'name': 'Pornanong Aramwit, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}