Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-28 @ 5:12 AM
Study NCT ID:
NCT05002192
Status:
UNKNOWN
Last Update Posted:
2021-11-26
First Post:
2021-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077591', 'term': 'Eucalyptol'}, {'id': 'D000077222', 'term': 'Limonene'}, {'id': 'D000551', 'term': 'Ambroxol'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000081005', 'term': 'Cyclohexane Monoterpenes'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D001964', 'term': 'Bromhexine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003514', 'term': 'Cyclohexylamines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of cough-related symptoms improvement', 'timeFrame': '7 days', 'description': "Rate of cough-related symptoms improvement in the expectorant treatment of inpatients with community-acquired pneumonia. Compared the differences of the rates of cough improvement between the experiment group and the control group.\n\nThe cough-related symptoms are evaluated and recorded in the inpatients' medical records. All the descriptions of cough-related symptoms and assessments in every inpatient's medical records will be captured."}], 'secondaryOutcomes': [{'measure': 'Rate of overal cure and improvement in pneumonia treatment', 'timeFrame': 'Up to 30 days', 'description': 'The overal pneumonia treatment results, include cured, improved, dead and other states, are assessed and recorded in the discharge summaries. The overal cure and improvement rate calculation in every group is based on the cured and improved states.'}, {'measure': 'Hospitalization length of stay', 'timeFrame': 'Up to 30 days', 'description': 'The mean hospitalization length of stay in every group is analyzed according the discharge summaries.'}, {'measure': 'Rate of pulmonary imageological improvement', 'timeFrame': 'Up to 30 days', 'description': 'The pulmonary imageological resultes include improved, deteriorative and unchanged states. The improvement rate calculation in every group is based on the improved state according to the last imageological reports before discharge.'}, {'measure': 'Rate of normalization of vital signs', 'timeFrame': '7 days', 'description': 'The vital signs, include temperature, pulse and respirations, are measured during the pre and post treatment. The normalization rate of vital signs is analyzed among the patients with abnormal vital signs measurements before treatment.'}, {'measure': 'Rate of normalization of inflammatory index of pneumonia', 'timeFrame': '7 days', 'description': 'The Inflammatory indexes of pneumonia, include CRP, PCT, SAA, WBC, IL-6 and lymphocyte count, are measured during the pre and post treatment. The normalization rates of inflammatory indexes of pneumonia are analyzed among the patients with abnormal indexes measurements before treatment'}, {'measure': 'Safety assessment: adverse events', 'timeFrame': 'Up to 30 days after first dose', 'description': 'Assess safety through monitoring of adverse events, and the collection of conventional laboratory data. All the adverse events during the pre and post treatment will be captured.'}, {'measure': 'Cost-effectiveness ratio', 'timeFrame': 'Up to 30 days', 'description': 'The all-cause healthcare will be determined by all the costs happened during the whole hospital stays (i.e.,skilled nursing facility, total medical, prescriptions). Effectiveness will be measured by the primary outcome, the rate of cough-related symptoms improvement within 7 days. The cost-effectiveness ratio is determined by the ratio of the all-cause healthcare to the rate of cough-related symptoms improvement within 7 days.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Community-acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '29757717', 'type': 'BACKGROUND', 'citation': 'Koo HJ, Lim S, Choe J, Choi SH, Sung H, Do KH. Radiographic and CT Features of Viral Pneumonia. Radiographics. 2018 May-Jun;38(3):719-739. doi: 10.1148/rg.2018170048.'}, {'pmid': '32053470', 'type': 'BACKGROUND', 'citation': 'Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.'}, {'pmid': '30551404', 'type': 'BACKGROUND', 'citation': 'Wang C, Shi QP, Ding F, Jiang XD, Tang W, Yu ML, Cheng JQ. Reevaluation of the post-marketing safety of Xuebijing injection based on real-world and evidence-based evaluations. Biomed Pharmacother. 2019 Jan;109:1523-1531. doi: 10.1016/j.biopha.2018.10.190. Epub 2018 Nov 14.'}, {'pmid': '7249508', 'type': 'BACKGROUND', 'citation': 'Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.'}, {'pmid': '18095744', 'type': 'BACKGROUND', 'citation': 'Agbabiaka TB, Savovic J, Ernst E. Methods for causality assessment of adverse drug reactions: a systematic review. Drug Saf. 2008;31(1):21-37. doi: 10.2165/00002018-200831010-00003.'}, {'pmid': '8995086', 'type': 'BACKGROUND', 'citation': 'Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, Coley CM, Marrie TJ, Kapoor WN. A prediction rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med. 1997 Jan 23;336(4):243-50. doi: 10.1056/NEJM199701233360402.'}, {'pmid': '20660689', 'type': 'BACKGROUND', 'citation': 'van Rensburg DJ, Perng RP, Mitha IH, Bester AJ, Kasumba J, Wu RG, Ho ML, Chang LW, Chung DT, Chang YT, King CH, Hsu MC. Efficacy and safety of nemonoxacin versus levofloxacin for community-acquired pneumonia. Antimicrob Agents Chemother. 2010 Oct;54(10):4098-106. doi: 10.1128/AAC.00295-10. Epub 2010 Jul 26.'}], 'seeAlsoLinks': [{'url': 'https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDZHYX&filename=ZHJH201604008&v=qCuiG%25mmd2F6QNYtzfsAcmKWVee6oAWq7A%25mmd2F32bE%25mmd2FeyB4Sz843vxcLKscnAXXNuoEjHP38', 'label': 'Related Info'}, {'url': 'https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2013&filename=HAIX201305046&v=9Bc6MSciMFxPiuSHHUHgKHy%25mmd2BB6g9VdyRglS96XjiAVg4Z3R6D%25mmd2BV%25mmd2BagbXJXq7BQmB', 'label': 'Related Info'}, {'url': 'https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2011&filename=QQHB201105043&v=1Gp4My%25mmd2FD4duhXu2aD9QZl7%25mmd2BzB6fkakB16oSdSHnf54lz%25mmd2FLhI9clExLJsVkqLE6xh', 'label': 'Related Info'}, {'url': 'https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDLAST2015&filename=XDJH201501031&v=%25mmd2BG%25mmd2F4hJcGfPCcVOIDUUrO0hSzjW8XkEPNvnSYnjvPm3e9bJJf%25mmd2FK4ZR9KMlF3ImMEn', 'label': 'Related Info'}, {'url': 'https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDLAST2019&filename=ZGUD201906015&v=yFr2CoeGjL0Lk26b2lZ%25mmd2FrHIuQmQuK1qiX1440YHCv%25mmd2BmpZAy3bK%25mmd2B26WjZ9u8LBq0S', 'label': 'Related Info'}, {'url': 'https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDLAST2018&filename=GWZW201804019&v=ULRpRwDBDzFsFtLHuMrsxZvSAfj1bLKb%25mmd2BKzXulrceZt1%25mmd2F%25mmd2BZFNBaAA%25mmd2F4Ad9ZnhlEZ', 'label': 'Related Info'}, {'url': 'http://www.bjjiuhe.com/product/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Through a series of retrospective analysis, it is hoped that an objective evaluation of the effect and safety of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the treatment of community-acquired pneumonia can be made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study adopts a retrospective research design to analyze the real-world data of Eucalyptol, Limonene and Pinene Enteric Soft Capsules, to evaluate the effectiveness, safety and economy of Eucalyptol, Limonene and Pinene Enteric Soft Capsules in the real clinical treatment of community-acquired pneumonia patients.\n\nIt is estimated that approximately 10,000 subjects from the six hospitals will meet the enrollment criteria to enter this retrospective real-world study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with community-acquired pneumonia\n2. Inpatients from 2017 to 2019\n3. Regardless of age and gender\n\nExclusion Criteria:\n\n1. Patients diagnosed with hospital-acquired pneumonia\n2. Patients who take two or more oral mucolytics\n3. Patients with combined use of Chinese and Western expectorants other than mucolytic drugs'}, 'identificationModule': {'nctId': 'NCT05002192', 'briefTitle': 'A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Grand Johamu Pharmaceutical Company, Ltd.'}, 'officialTitle': 'A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia', 'orgStudyIdInfo': {'id': 'YD_SMQD_ELP_202009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ELP_ONLY', 'description': 'Patients who were diagnosed with community-acquired pneumonia and were treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules, not treated with other oral mucolytics.', 'interventionNames': ['Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule']}, {'label': 'EXP_ONLY', 'description': 'Patients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.', 'interventionNames': ['Drug: Other oral mucolytic drugs']}, {'label': 'ELP+AMB', 'description': 'Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.', 'interventionNames': ['Drug: Eucalyptol, Limonene and Pinene Enteric Soft Capsule', 'Drug: Ambroxol injection']}, {'label': 'EXP+AMB', 'description': 'Patients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.', 'interventionNames': ['Drug: Ambroxol injection', 'Drug: Other oral mucolytic drugs']}, {'label': 'AMB_ONLY', 'description': 'Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone.', 'interventionNames': ['Drug: Ambroxol injection']}], 'interventions': [{'name': 'Eucalyptol, Limonene and Pinene Enteric Soft Capsule', 'type': 'DRUG', 'description': 'Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\\_ONLY and EXP\\_ONLY cohort', 'armGroupLabels': ['ELP+AMB', 'ELP_ONLY']}, {'name': 'Ambroxol injection', 'type': 'DRUG', 'description': 'Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and cohort EXP+AMB Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB\\_ONLY cohort Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB\\_ONLY cohort', 'armGroupLabels': ['AMB_ONLY', 'ELP+AMB', 'EXP+AMB']}, {'name': 'Other oral mucolytic drugs', 'type': 'DRUG', 'description': 'Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\\_ONLY and EXP\\_ONLY cohort', 'armGroupLabels': ['EXP+AMB', 'EXP_ONLY']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bingbing Wu, Associate Chief Physician', 'role': 'CONTACT', 'email': 'dr_bingbingl@sina.com', 'phone': '13661179832'}], 'facility': 'Peking University Peoples Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weihua Lai, Chief Pharmacist', 'role': 'CONTACT', 'email': 'laiweihuax@163.com', 'phone': '13570042336'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'WITHDRAWN', 'country': 'China', 'facility': 'The First Affiliated Hospital Of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518037', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianlong Wu, Chief Pharmacist', 'role': 'CONTACT', 'email': 'wjl06@163.com', 'phone': '13802555718'}], 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zhao, Chief Physician', 'role': 'CONTACT', 'email': '941615059@qq.com', 'phone': '13995577963'}, {'name': 'Xianlong Zhou, Physician-in-charge', 'role': 'CONTACT', 'email': 'xianlongzhou@whu.edu.cn', 'phone': '18627839314'}, {'name': 'Yan Zhao, Chief Physician', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '200020', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jieming Qu, Chief Physician', 'role': 'CONTACT', 'email': 'puffymoonlight@126.com', 'phone': '18901661180'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinfu Xu, Chief Physician', 'role': 'CONTACT', 'email': 'jfxucn@163.com', 'phone': '13321922898'}, {'name': 'Haiwen Lu, Associate Chief Physician', 'role': 'CONTACT', 'email': 'haiwen_lu@163.com', 'phone': '13917110982'}, {'name': 'Jinfu Xu, Chief Physician', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Grand Johamu Pharmaceutical Company, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}