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

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Pneumonia

Treatments: Drug: TCM

Study type: Observational

Funder types: Other

Identifiers

NCT06220019

RESEARCH-Pneumonia

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Selection Criteria:

• Hospitalized patients with a confirmed diagnosis of pneumonia (HAP, CAP).
• Age ≥18 years.
• Signed informed consent form.

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.

Trial design

5,000 participants in 2 patient groups

TCM Group

Description:

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.

Treatment:

Drug: TCM

Non-TCM Group

Description:

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