A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
1 other identifier
observational
10,000
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 26, 2021
July 1, 2021
1.3 years
July 12, 2021
November 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of cough-related symptoms improvement
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. The 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.
7 days
Secondary Outcomes (7)
Rate of overal cure and improvement in pneumonia treatment
Up to 30 days
Hospitalization length of stay
Up to 30 days
Rate of pulmonary imageological improvement
Up to 30 days
Rate of normalization of vital signs
7 days
Rate of normalization of inflammatory index of pneumonia
7 days
- +2 more secondary outcomes
Study Arms (5)
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.
EXP_ONLY
Patients diagnosed with community-acquired pneumonia and treated with an oral mucolytic drug other than Eucalyptol, Limonene and Pinene Enteric Soft Capsules.
ELP+AMB
Patients diagnosed with community-acquired pneumonia and treated with Eucalyptol, Limonene and Pinene Enteric Soft Capsules and ambroxol injection.
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.
AMB_ONLY
Patients diagnosed with community-acquired pneumonia and treated with ambroxol injection alone.
Interventions
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
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
Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort
Eligibility Criteria
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. It is estimated that approximately 10,000 subjects from the six hospitals will meet the enrollment criteria to enter this retrospective real-world study.
You may qualify if:
- Patients with community-acquired pneumonia
- Inpatients from 2017 to 2019
- Regardless of age and gender
You may not qualify if:
- Patients diagnosed with hospital-acquired pneumonia
- Patients who take two or more oral mucolytics
- Patients with combined use of Chinese and Western expectorants other than mucolytic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518037, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (7)
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: 29757717BACKGROUNDPan 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: 32053470BACKGROUNDWang 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: 30551404BACKGROUNDNaranjo 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: 7249508BACKGROUNDAgbabiaka 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: 18095744BACKGROUNDFine 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: 8995086BACKGROUNDvan 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.
PMID: 20660689BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2021
First Posted
August 12, 2021
Study Start
September 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
November 26, 2021
Record last verified: 2021-07