REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-26

Study Completion Date

2027-12-31

Brief Summary

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The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.

Detailed Description

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The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia.

This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.

Conditions

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Pneumonia

Keywords

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Pneumonia Chinese Medicine Cohort

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TCM Group

The study will include adult patients discharged after hospitalization for pneumonia, with no restrictions on TCM syndromes. Patients diagnosed with pneumonia via laboratory or imaging tests at admission and treated in the hospital will be eligible if enrolled within seven days of discharge. Follow-ups will occur every three months over one year, documenting treatment methods (TCM or Western medicine), hospitalizations, respiratory infections, mortality, and quality of life.

Subgroup analyses will be conducted based on age, type of pneumonia (community- or hospital-acquired), specific TCM treatments (e.g., Chinese patent medicines or external therapies), and treatment duration.

TCM

Intervention Type DRUG

We will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM.

Non-TCM Group

All patients who do not meet the defined criteria for the TCM group will be classified into the non-TCM group.

No interventions assigned to this group

Interventions

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TCM

We will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
* Patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions;
* Those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials.
* Known to be allergic to treatment drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiansheng Li, Doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Central Contacts

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Minghang Wang, Doctor

Role: CONTACT

Phone: +86 371 66248624

Email: [email protected]

Other Identifiers

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RESEARCH-Pneumonia

Identifier Type: -

Identifier Source: org_study_id