TCM Cohort for Elderly CAP
2026年8月28日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
2234
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Haifeng Wang
- 电话号码：+86-0371-66207856
- 邮箱：wangh_f@126.com
研究联系人备份
- 姓名：Jiansheng Li
学习地点
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Henan
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Zhengzhou、Henan、中国、450000
- The First Affiliated Hospital of Henan University of Chinese Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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).
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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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所有不符合TCM暴露标准的干预措施都被视为非TCM暴露。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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90-day all-cause readmission rate
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Length of hospital stay
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Haifeng Wang、The First Affiliated Hospital of Henan University of Chinese Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月20日
初级完成 (估计的)
2029年12月31日
研究完成 (估计的)
2030年2月28日
研究注册日期
首次提交
2026年8月19日
首先提交符合 QC 标准的
2026年8月28日
首次发布 (实际的)
2026年9月1日
研究记录更新
最后更新发布 (实际的)
2026年9月1日
上次提交的符合 QC 标准的更新
2026年8月28日
最后验证
2026年8月1日
更多信息
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