TCM Cohort for Elderly CAP

NCT07797686 | Not Yet Recruiting DMC

• 1 other identifier: Cohort for Elderly CAP
• Study Type: observational
• Target: 2,234
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the real-world clinical efficacy of traditional Chinese medicine (TCM) in elderly Community-acquired pneumonia (CAP) patients and explores syndrome characteristics and their associations with biomarkers.

Conditions

Community-acquired Pneumonia (CAP)

Keywords

Community-acquired Pneumonia in the Elderly; Cohort Study; Traditional Chinese Medicine Syndromes; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 90-day all-cause readmission rate

  The 90-day all-cause readmission rate will be calculated in each group at the end of the trial.

  Up to week 12.

Secondary Outcomes (7)

• Length of hospital stay

  From Day 0 of treatment to Week 2 of follow-up.

• Time to clinical stability

  From enrollment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to Week 2.

• modified Clinician Reported Outcome for CAP (mCAP-CRO)

  Baseline, weeks 1, 4 and 12.

• modified Patient Reported Outcome for CAP (mCAP-PRO)

  Baseline, weeks 1, 4 and 12.

• Sequential Organ Failure Assessment (SOFA)

  Baseline, weeks 1, 4 and 12.

Study Arms (2)

Traditional Chinese Medicine cohort

Regulated use of Chinese medicine treatment protocols is included as an exposure factor.

Drug: Traditional Chinese medicine (TCM)

Non-Traditional Chinese Medicine cohort

Other elderly CAP patients who do not meet the inclusion criteria for traditional Chinese medicine cohort, are classified into the non-traditional Chinese medicine cohort.

Drug: Non-traditional Chinese medicine (non-TCM)

Interventions

Traditional Chinese medicine (TCM) DRUG

According to the standardised use of TCM protocols, the group is divided into an exposed group (TCM cohort) and an unexposed group (non-TCM cohort).

Traditional Chinese Medicine cohort

Non-traditional Chinese medicine (non-TCM) DRUG

All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.

Non-Traditional Chinese Medicine cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CAP refers to infectious inflammation of the lung parenchyma that is acquired outside the hospital, and includes pneumonia that develops during the incubation period after hospitalization when the infection is caused by a pathogen with a known incubation period.

You may qualify if:

• Patients diagnosed with CAP;
• Age ≥ 60 years old;
• Voluntary participation in this study, and sign the informed consent form.

You may not qualify if:

• Patients with various mental illnesses or other conditions that prevent normal communication;
• Patients with a history of pulmonary surgery, such as lung volume reduction surgery or lung transplantation;
• Patients with confirmed human immunodeficiency virus infection or acquired immunodeficiency syndrome.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen Description: Blood, Exhaled breath condensate, Tongue coating, Sputum

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Haifeng Wang

  The First Affiliated Hospital of Henan University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haifeng Wang

CONTACT

+86-0371-66207856; wangh_f@126.com

Jiansheng Li

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 1, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

CN (1)