A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
NCT ID: NCT05002192
Last Updated: 2021-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
10000 participants
OBSERVATIONAL
2020-09-01
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ELP_ONLY
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.
Eucalyptol, Limonene and Pinene Enteric Soft Capsule
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
EXP_ONLY
Patients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
Other oral mucolytic drugs
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
ELP+AMB
Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.
Eucalyptol, Limonene and Pinene Enteric Soft Capsule
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
Ambroxol injection
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
EXP+AMB
Patients diagnosed with community-acquired pneumonia and treated with oral mucolytics and ambroxol injection other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
Ambroxol injection
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
Other oral mucolytic drugs
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
AMB_ONLY
Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone.
Ambroxol injection
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eucalyptol, Limonene and Pinene Enteric Soft Capsule
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
Ambroxol injection
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
Other oral mucolytic drugs
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Inpatients from 2017 to 2019
3. Regardless of age and gender
Exclusion Criteria
2. Patients who take two or more oral mucolytics
3. Patients with combined use of Chinese and Western expectorants other than mucolytic drugs
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Grand Johamu Pharmaceutical Company, Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bingbing Wu, Associate Chief Physician
Role: primary
Weihua Lai, Chief Pharmacist
Role: primary
Jianlong Wu, Chief Pharmacist
Role: primary
Yan Zhao, Chief Physician
Role: primary
Xianlong Zhou, Physician-in-charge
Role: backup
Jieming Qu, Chief Physician
Role: primary
Jinfu Xu, Chief Physician
Role: primary
Haiwen Lu, Associate Chief Physician
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YD_SMQD_ELP_202009
Identifier Type: -
Identifier Source: org_study_id