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

ConditionPneumonia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorHenan University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalized patients with a confirmed diagnosis of pneumonia (HAP, CAP).

Age ≥18 years.

Signed informed consent form.

Disqualifiers

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 population

Adult patients discharged after pneumonia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • TCM

    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.

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: TCM Group1 intervention
Group B: Non-TCM Group0 interventions

Trial outcomes

Primary outcomes

1

Rehospitalization rate

Including all-cause readmission rate and pulmonary infection readmission rate

Time frame
The Rehospitalization rate within a one-year follow-up period

Secondary outcomes

1

Patient satisfaction with efficacy

The Effectiveness Satisfaction Questionnaire of CAP (ESQ-CAP) was used to evaluate the efficacy of pneumonia patients.

Time frame
Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
2

Health survey summary table（SF-36）

Using SF-36 to evaluate the impact of CAP on a person's life over time

Time frame
Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
3

Clinical outcomes reported by patients

The Patient Reported Outcome for CAP (CAP-PRO) was used to assess the quality of life and health status of patients with pneumonia.

Time frame
Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
4

Clinical outcomes reported by doctors

The Clinical Reported Outcome for CAP (CAP CRO) was used to assess the patient's condition.

Time frame
Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan University of Traditional Chinese Medicine

Lead sponsor

Wuhan No.1 Hospital

Collaborator

Hebei Provincial Hospital of Traditional Chinese Medicine

Collaborator

Shanghai University of Traditional Chinese Medicine

Collaborator

Qingdao Hiser Medical Group

Collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator

Shaanxi Hospital of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: