TCM Cohort for Elderly COPD
2026年8月19日 更新者：Henan University of Traditional Chinese Medicine
A Prospective Traditional Chinese Medicine Cohort Study of Chronic Obstructive Pulmonary Disease in the Elderly
This study evaluates the real-world clinical efficacy of traditional Chinese medicine (TCM) in elderly Chronic obstructive pulmonary disease (COPD) 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 2,386 elderly COPD patients for a 1-year follow-up. The primary evaluation uses the annual acute exacerbation 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 COPD patients with four typical TCM syndromes, 200 non-elderly COPD 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)
2386
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
COPD is a common chronic respiratory disease characterized by persistent respiratory symptoms and airflow limitation, with recurrent acute exacerbations and progressive impairment of respiratory function.
描述
Inclusion Criteria:
- Patients diagnosed with COPD;
- 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 COPD 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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Annual acute exacerbation rate
大体时间：Up to week 52.
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The annual acute exacerbation rate will be calculated in each group at the end of the trial.
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Up to week 52.
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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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Forced Vital Capacity (FVC)
大体时间：Evaluate the FVC at weeks 26 and 52.
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FVC will be applied to assess pulmonary function.
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Evaluate the FVC at weeks 26 and 52.
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Forced Expiratory Volume in One Second (FEV1)
大体时间：Evaluate the FEV1 at weeks 26 and 52.
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FEV1 will be applied to assess pulmonary function.
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Evaluate the FEV1 at weeks 26 and 52.
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FEV1/FVC Ratio
大体时间：Evaluate the FEV1/FVC Ratio at weeks 26 and 52.
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FEV1/FVC Ratio will be applied to assess pulmonary function.
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Evaluate the FEV1/FVC Ratio at weeks 26 and 52.
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6-Minute Walk Distance (6MWD)
大体时间：Evaluate the 6MWD at weeks 26 and 52.
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The 6MWD will be applied to evaluate the exercise capacity.
The higher values indicate the better exercise capacity.
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Evaluate the 6MWD at weeks 26 and 52.
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COPD Assessment Test (CAT) Score
大体时间：Evaluate the CAT Score at weeks 13, 26, 39 and 52.
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The CAT score is a questionnaire used to evaluate the impact of COPD on patients' health status, which includes eight items: cough, phlegm, chest tightness, breathlessness, activity limitation, confidence in leaving home, sleep, and energy.
The total CAT score ranges from 0 to 40, with higher scores indicating a greater disease burden and poorer health status.
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Evaluate the CAT Score at weeks 13, 26, 39 and 52.
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Modified Medical Research Council (mMRC) Dyspnea Scale
大体时间：Evaluate the mMRC at weeks 13, 26, 39 and 52.
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The mMRC is a scale used to evaluate the severity of dyspnea in patients, which consists of a single item with five grades ranging from 0 to 4. Higher grades indicate more severe dyspnea and greater limitations in daily activities.
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Evaluate the mMRC at weeks 13, 26, 39 and 52.
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St. George's respiratory questionnaire (SGRQ) total scores
大体时间：Evaluate the SGRQ Score at weeks 13, 26, 39 and 52.
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The SGRQ is a scale used to evaluate the quality of life of patients, which includes three dimensions: symptoms, mobility, and the impact of disease on daily life, with a total of 50 items.
The total score range of SGRQ is usually between 0 and 100, with higher scores leading to poorer quality of life.
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Evaluate the SGRQ Score at weeks 13, 26, 39 and 52.
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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。
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19日
首次发布 (实际的)
2026年8月21日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月19日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.