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A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia

A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05002192
Enrollment
10000
Registered
2021-08-12
Start date
2020-09-01
Completion date
2022-12-31
Last updated
2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

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.

Interventions

DRUGEucalyptol, 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

DRUGAmbroxol 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

DRUGOther oral mucolytic drugs

Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP\_ONLY and EXP\_ONLY cohort

Sponsors

Beijing Grand Johamu Pharmaceutical Company, Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients with community-acquired pneumonia 2. Inpatients from 2017 to 2019 3. Regardless of age and gender

Exclusion criteria

1. Patients diagnosed with hospital-acquired pneumonia 2. Patients who take two or more oral mucolytics 3. Patients with combined use of Chinese and Western expectorants other than mucolytic drugs

Design outcomes

Primary

MeasureTime frameDescription
Rate of cough-related symptoms improvement7 daysRate 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.

Secondary

MeasureTime frameDescription
Hospitalization length of stayUp to 30 daysThe mean hospitalization length of stay in every group is analyzed according the discharge summaries.
Rate of pulmonary imageological improvementUp to 30 daysThe 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.
Rate of normalization of vital signs7 daysThe 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.
Rate of overal cure and improvement in pneumonia treatmentUp to 30 daysThe 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.
Safety assessment: adverse eventsUp to 30 days after first doseAssess 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.
Cost-effectiveness ratioUp to 30 daysThe 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.
Rate of normalization of inflammatory index of pneumonia7 daysThe 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026