Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT03384667
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119571', 'term': 'maimendongtang'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-blind, placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leicester Cough Questionnaire (LCQ)', 'timeFrame': 'Day 0 to Day 28', 'description': 'Questionnaire used to measure quality of life in cough patients. The total score of LCQ is 3 to 21, and a higher score means a better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Cough VAS', 'timeFrame': 'Day 0 to Day 28', 'description': 'Measure frequency and severity of cough by VAS'}, {'measure': 'Yin deficiency scale', 'timeFrame': 'Day 0 to Day 28', 'description': 'Questionnaire measures yin deficiency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maekmoondong-tang', 'Mai-men-dong-tang', 'Bakumondo-to'], 'conditions': ['Postoperative Cough', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the efficacy and safety of Maekmoondong-tang on post-operative cough in patients with lung cancer. A randomized, double-blind, placebo-controlled trial will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 20 years old.\n* Patients undergone segmentectomy or lobectomy for lung cancer within 1 month\n* Patients who do not or poorly respond to one week administration of common antitussive agents.\n* Eastern Cooperative Oncology Group(ECOG) 0 to 2\n* Participant is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patients undergoing adjuvant chemotherapy.\n* Patients who have been diagnosed with acute respiratory disease within 1 month.\n* Patients who have been diagnosed with bronchial asthma or bronchiectasis within 1 year\n* Patients taking Angiotensin Converting Enzyme Inhibitor\n* Patients with pseudoaldosteronism.\n* Participants who have known prior hypersensitivity to any investigational product component\n* Patient with acute or chronic infections requiring treatment (active HAV, HBV, HCV, HIV, TB)\n* Pregnant or lactating females\n* Women of childbearing potential\n* Patient who do not agrees to use effective means of contraception and not to donate sperm during the trial and up to 1 month after final administration\n* Patient who participated other clinical trials of medicine or medical devices within 1 month\n* Individuals who are judged inappropriate for the study by investigator'}, 'identificationModule': {'nctId': 'NCT03384667', 'briefTitle': 'Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'officialTitle': 'Efficacy and Safety Evaluation of Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer -Randomized, Double-blind, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'ISEE_MMDT_2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MMDT group', 'interventionNames': ['Drug: Maekmoondong-tang']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Maekmoondong-tang', 'type': 'DRUG', 'otherNames': ['Maekgeuron Granules'], 'description': 'MMDT is a Herbal medicine consist of six herbs.', 'armGroupLabels': ['MMDT group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The granules do not contain any active ingredients.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-701', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyojin Son', 'role': 'CONTACT', 'email': 'crisphj@naver.com', 'phone': '82-2-2626-1185'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Chunhoo Cheon, Dr.', 'role': 'CONTACT', 'email': 'hreedom35@gmail.com', 'phone': '8229619278'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seong-Gyu Ko', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Seong-Gyu Ko', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}