An observational study in Community-acquired Pneumonia (CAP), sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Henan University of Traditional Chinese Medicine · Observational
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.
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.
324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.
This study's planned enrollment of 2,234 is above the median of 650 across 111 observational studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 55 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Regulated use of Chinese medicine treatment protocols is included as an exposure factor.
Drug: Traditional Chinese medicine (TCM)
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)
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).
All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.
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.
Time frame: Up to week 12.
Length of hospital stay
Total number of days of hospitalization.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, weeks 1, 4 and 12.
Start is estimated for Aug 2026; primary completion for Dec 2029, 40 months later.
Of 38 observational studies under Community-Acquired Pneumonia, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's planned 40 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Community-Acquired Pneumonia →
Henan University of Traditional Chinese Medicine