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NCT Number: NCT06220019

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rehospitalization rate

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

    Including all-cause readmission rate and pulmonary infection readmission rate

Secondary outcomes

  1. Patient satisfaction with efficacy

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

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

  2. Health survey summary table(SF-36)

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

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

  3. Clinical outcomes reported by patients

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

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

  4. Clinical outcomes reported by doctors

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

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

  5. nutritional status

    Time frame: Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage

    Nutritional status related indicators.

  6. Acute upper respiratory tract infection (URTI) event

    Time frame: Acute upper respiratory tract infection events that occurred during the one-year follow-up period

    It is a general term for acute inflammation of the nose, pharynx, or throat caused by various viruses and/or bacteria, including common cold, acute viral pharyngitis or laryngitis, acute herpetic pharyngitis, pharyngoconjunctival fever, bacterial pharyngitis, and tonsillitis.

  7. Survival situation

    Time frame: Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase

    Record the number of deaths. Record the follow-up period every 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Minghang Wang, Doctor

CONTACT

[email protected]

+86 371 66248624

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Collaborators

  • Hebei Provincial Hospital of Traditional Chinese Medicine
  • Qingdao Hiser Medical Group
  • Shaanxi Hospital of Traditional Chinese Medicine
  • Shanghai University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Zhejiang Chinese Medical University
  • Wuhan No.1 Hospital

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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