TCM Cohort for Elderly CAP

A Prospective Traditional Chinese Medicine Cohort Study of Community-acquired Pneumonia in the Elderly

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Community-acquired Pneumonia (CAP)
• Intervention / Treatment: Drug: Non-traditional Chinese medicine (non-TCM); Drug: Traditional Chinese medicine (TCM)

Detailed Description

This prospective cohort study, with TCM as the exposure, will enroll 2,234 elderly CAP patients for a 12-week follow-up. The primary evaluation uses the 90-day all-cause readmission rate as the outcome to evaluate the clinical efficacy of TCM. In addition, the study will investigate the characteristics of TCM syndromes.

Based on the cohort, we will collect peripheral blood, exhaled breath condensate, sputum, and tongue coating samples from 200 elderly CAP patients with four typical TCM syndromes, 200 non-elderly CAP patients with corresponding syndromes, and 50 healthy volunteers. Multi-omics approaches will be used to identify TCM syndrome-related biomarkers.

• Study Type: Observational
• Enrollment (Estimated): 2234

Contacts and Locations

• Study Contact: Name: Haifeng Wang; Phone Number: +86-0371-66207856; Email: wangh_f@126.com
• Study Contact Backup: Name: Jiansheng Li

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Henan University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traditional Chinese Medicine cohort; Regulated use of Chinese medicine treatment protocols is included as an exposure factor.	Drug: Traditional Chinese medicine (TCM); 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).
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); All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Total number of days of hospitalization.	From Day 0 of treatment to Week 2 of follow-up.
Time to clinical stability	Clinical stability is defined as meeting all of the following criteria simultaneously: body temperature < 37.8℃, heart rate ≤ 100 beats/min, respiratory rate ≤ 24 breaths/min, systolic pressure ≥ 90mmHg, and oxygen saturation ≥ 90% (or PaO2 < 60mmHg without oxygen inhale).	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)	Pneumonia-related clinical status will be assessed using the mCAP-CRO. The scale contains 11 clinician-reported items evaluating pneumonia-related symptoms and signs during the previous 24 hours and the clinician's overall assessment of disease improvement. Each item is scored from 1 to 5. Higher scores indicate more severe pneumonia-related symptoms and signs and less clinical improvement.	Baseline, weeks 1, 4 and 12.
modified Patient Reported Outcome for CAP (mCAP-PRO)	Pneumonia-related symptoms and patient-perceived health status will be assessed using the mCAP-PRO. The scale contains 17 patient-reported items evaluating pneumonia-related symptoms during the previous 24 hours, the effects of the illness on daily activities and work or study, and satisfaction with health status and treatment effectiveness. Each item is scored from 0 to 4. Higher scores indicate more severe pneumonia-related symptoms, greater impairment in daily functioning, and lower satisfaction with health status and treatment effectiveness.	Baseline, weeks 1, 4 and 12.
Sequential Organ Failure Assessment (SOFA)	The SOFA score will be used to assess the degree of organ dysfunction in elderly patients with severe CAP. The total SOFA score ranges from 0 to 24 points. The higher scores will indicate the worse outcomes.	Baseline, weeks 1, 4 and 12.
Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65)	The CURB-65 score will be used to assess the severity of elderly patients with CAP. The total score ranges from 0 to 5 points. The higher scores will indicate the worse outcomes.	Baseline, weeks 1, 4 and 12.
Pneumonia Severity Index (PSI)	The PSI will be used to assess the disease severity in elderly CAP patients. It stratifies patients into five risk classes (I-V) according to a point-scoring system, with higher scores consistently correlating with worse outcomes.	Baseline, weeks 1, 4 and 12.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: The First Affiliated Hospital of Guangzhou Medical University; First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Haifeng Wang, The First Affiliated Hospital of Henan University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: August 28, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Cohort Study; Traditional Chinese Medicine Syndromes; Community-acquired Pneumonia in the Elderly
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Pneumonia; Community-Acquired Infections; Community-Acquired Pneumonia; Therapeutics; Complementary Therapies; Medicine, East Asian Traditional; Medicine, Traditional; Medicine, Chinese Traditional
• Other Study ID Numbers: Cohort for Elderly CAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No