TCM Cohort for Elderly CAP
28. august 2026 opdateret af: Henan University of Traditional Chinese Medicine
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
2234
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Haifeng Wang
- Telefonnummer: +86-0371-66207856
- E-mail: wangh_f@126.com
Undersøgelse Kontakt Backup
- Navn: Jiansheng Li
Studiesteder
-
-
Henan
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Zhengzhou, Henan, Kina, 450000
- The First Affiliated Hospital of Henan University of Chinese Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Traditional Chinese Medicine cohort
Regulated use of Chinese medicine treatment protocols is included as an exposure factor.
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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.
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Alle interventionsforanstaltninger, der ikke opfylder kriterierne for TCM-eksponering, betragtes som ikke-TCM-eksponering.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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90-day all-cause readmission rate
Tidsramme: Up to week 12.
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The 90-day all-cause readmission rate will be calculated in each group at the end of the trial.
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Up to week 12.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Length of hospital stay
Tidsramme: From Day 0 of treatment to Week 2 of follow-up.
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Total number of days of hospitalization.
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From Day 0 of treatment to Week 2 of follow-up.
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Time to clinical stability
Tidsramme: From enrollment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to Week 2.
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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).
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From enrollment, the time is recorded until the patient reaches clinical stability, whichever came first, assessed up to Week 2.
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modified Clinician Reported Outcome for CAP (mCAP-CRO)
Tidsramme: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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modified Patient Reported Outcome for CAP (mCAP-PRO)
Tidsramme: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Sequential Organ Failure Assessment (SOFA)
Tidsramme: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Confusion, Urea, Respiratory rate, Blood pressure, Age≥65 (CURB-65)
Tidsramme: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Pneumonia Severity Index (PSI)
Tidsramme: Baseline, weeks 1, 4 and 12.
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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.
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Baseline, weeks 1, 4 and 12.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Haifeng Wang, The First Affiliated Hospital of Henan University of Chinese Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
20. august 2026
Primær færdiggørelse (Anslået)
31. december 2029
Studieafslutning (Anslået)
28. februar 2030
Datoer for studieregistrering
Først indsendt
19. august 2026
Først indsendt, der opfyldte QC-kriterier
28. august 2026
Først opslået (Faktiske)
1. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Cohort for Elderly CAP
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