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

NCT06220019 | Not Yet Recruiting DMC

• 1 other identifier: RESEARCH-Pneumonia
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pneumonia

Keywords

Pneumonia; Chinese Medicine; Cohort

Outcome Measures

Primary Outcomes (1)

• Rehospitalization rate

  Including all-cause readmission rate and pulmonary infection readmission rate

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

Secondary Outcomes (7)

• Patient satisfaction with efficacy

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

• Health survey summary table（SF-36）

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

• Clinical outcomes reported by patients

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

• Clinical outcomes reported by doctors

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

• nutritional status

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

Study Arms (2)

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.

Drug: 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.

Interventions

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.

TCM Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients discharged after pneumonia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biological sample bank includes serum samples, plasma samples, urine samples, stool samples.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiansheng Li, Doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Minghang Wang, Doctor

CONTACT

+86 371 66248624; wmh107hn@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 23, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 30, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share