Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT04812561
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2021-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Bronch™ on Respiratory Health
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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-21', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-03-21', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores', 'timeFrame': 'screening, 6, 12 week', 'description': 'CAT were measured in study screening, visit 2(6 week), visit 3(12 week). CAT was developed for use as a way to assess the quality of life of COPD patients, consisting of eight items, each of which evaluates 0 to 5 points, and the sum of all eight item scores is the CAT score. The best quality of life is 0 points, and the worst is 40 points.'}, {'measure': 'Changes of BCSS(Breathlessness, Cough, and Sputum Scale) scores', 'timeFrame': '0, 6, 12 week', 'description': 'BCSS were measured in study visit 1(0 week), visit 2(6 week), visit 3(12 week). BCSS is a scale for evaluating symptoms of Breathlessness, cough, and sputum, which is a major symptom of COPD(Chronic obstructive pulmonary disease), and symptoms of Breathlessness, cough, and sputum are evaluated in five stages.\n\n\\<Breathlessness, sputum\\> 0: never, 1: rare, 2: occasionally, 3: often, 4: almost always \\<Cough\\> 0: never, 1: a little hard, 2: moderate extent of hard, 3: over moderate extent of hard, 4: serious hard'}], 'secondaryOutcomes': [{'measure': 'FVC(Forced vital capacity)', 'timeFrame': 'screening, 12 week', 'description': 'The Forced vital capacity(FVC) was measured Flow rate discharged during the hard-working unit before and after the intervention.'}, {'measure': 'FEV1(Forced expiratory volume in 1 second)', 'timeFrame': 'screening, 12 week', 'description': 'The Forced expiratory volume in 1 second(FEV1) was assessed before and after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Health', 'Korean mint', 'licorice'], 'conditions': ['Respiratory Health']}, 'descriptionModule': {'briefSummary': 'This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.', 'detailedDescription': 'This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 60 subjects were randomly divided into Bronch™ group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking one pill twice a day, in comparison with taking a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19-80 years at screening\n* nonsmoker\n* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice\n\nExclusion Criteria:\n\n* Participants with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders\n* Participants who have Body Mass Index(BMI) less than 18.5 kg/m\\^2 or more than 35 kg/m\\^2\n* Participants who have taken medication or dietary supplements related to the respiratory disease within 1 months prior to screening\n* Participants with a history of antipsychotic medication use within 3 months prior to the screening examination\n* Participants who alcoholic or drug abuse suspected\n* Participants who have participated in the other human trials within 3 months before the screening test\n* Laboratory test by show the following results\n\n * AST, ALT \\> Reference range 3 times upper limit\n * Serum Creatinine \\> 2.0 mg/dL\n* Pregnancy or breast feeding\n* Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes'}, 'identificationModule': {'nctId': 'NCT04812561', 'briefTitle': 'Effects of Bronch™ on Respiratory Health', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Bronch™ on Respiratory Health', 'orgStudyIdInfo': {'id': 'NS_Bronch_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bronch™ group', 'description': '2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day, 800 mg/day as Bronch™)', 'interventionNames': ['Dietary Supplement: Bronch™']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day)', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Bronch™', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week', 'armGroupLabels': ['Bronch™ group']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo-Wan Chae, MD., PhD', 'role': 'CONTACT', 'email': 'swchae@jbctc.org', 'phone': '82-63-259-3040'}], 'facility': 'Clinical Trial Center for Functional Foods Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'centralContacts': [{'name': 'Soo Wan Chae, Ph.D., M.D.', 'role': 'CONTACT', 'email': 'soowan@jbnu.ac.kr', 'phone': '82-63-259-3040'}]}, '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'}}}}