跳至主要内容
临床试验/NCT06577701
NCT06577701尚未招募不适用

Respiratory Disease Cohort Studies of Chinese Medicine for Chronic Obstructive Pulmoriary Disease (RESEARCH-COPD)

Henan University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10,000
试验地点
1
主要终点
Frequencies of acute exacerbations (AEs)

研究概览

简要总结

This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine against COPD will be established.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease with high prevalence, high mortality rate, high disability rate and heavy disease burden, seriously endangering people's health. The prevalence of COPD among people aged 40 and above in China is 13.7%, with nearly 100 million patients. The situation of high prevalence, high mortality, and high disability is not matched by the low awareness rate, low lung function test rate, and low treatment rate, which is a serious situation for prevention and control. 2021 edition of 'Global Initiative on Chronic Obstructive Lung Disease (GOLD)' puts forward the concept of pre-COPD, which indicates that the concept of prevention and treatment of COPD has begun to change to prevention and early intervention, and is also related to the concept of intermediate medicine. The concept of pre-COPD has been proposed in the 2021 edition of GOLD, indicating that the concept of prevention and treatment of COPD has begun to shift towards prevention and early intervention, which is also in line with the idea of 'treating the disease before it is diagnosed' in TCM. Chinese medicine has certain advantages in the prevention and treatment of COPD. Currently, there is a lack of TCM diagnostic and treatment protocols for the early stage of COPD, and TCM diagnostic and treatment protocols for the stable stage of COPD need to be optimised. Therefore, based on the Chinese COPD registry management system, this study took the pre-CPD population and stable stage patients as the research object, and used the standardised use of Chinese medicine diagnostic and treatment protocols as the exposure factor to carry out a multicentre prospective cohort study, with a follow-up of 2 years, using the morbidity rate, the rate of decline in lung function FEV1, etc., to evaluate the efficacy of Chinese medicine diagnostic and treatment protocols for pre-COPD, and using the rate of occurrence of acute exacerbation, The efficacy of TCM treatment protocols for patients with stable COPD was further evaluated using the incidence of acute exacerbation and quality of survival. This will provide high-quality evidence-based medical evidence for the prevention and treatment of COPD by TCM.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meets diagnostic criteria for chronic obstructive pulmonary disease (COPD) or preserved ratio impaired spirometry (PRISm).
  • Age ranges from 18 years to 80 years.
  • The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

排除标准

  • Patients with delirium, dementia, various mental illnesses.
  • Pregnant and planned pregnant or lactating women.
  • Patients with other serious systemic diseases.
  • Patients who, in the opinion of the investigator, are not suitable for participation in this study.

研究组 & 干预措施

Traditional Chinese Medicine cohort

Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Continuous medication for more than 3 months per year, or intermittent medication for more than 6 months per year was the exposure group (TCM diagnosis and treatment plan cohort).

干预措施: traditional Chinese medicine (TCM) (Drug)

Non Traditional Chinese Medicine cohort

Other patients who did not fit into the TCM group.

干预措施: non traditional Chinese medicine (non-TCM) (Drug)

结局指标

主要结局

Frequencies of acute exacerbations (AEs)

时间窗: Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.

The frequencies of acute exacerbations (AEs) will be recorded.

Incidence of COPD

时间窗: 24 months after enrollment.

The incidence of COPD will be recorded.

次要结局

  • Forced expiratory volume in one second (FEV1)(Change from baseline FEV1 at months 6, 12, 18 and 24.)
  • 6 Six Minute Walk Distance (6MWD)(6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.)
  • Forced vital capacity (FVC)(Change from baseline FVC at months 6, 12, 18 and 24.)
  • Traditional Chinese medicine syndromes(The Traditional Chinese medicine syndromes at months 3, 6, 9, 12, 15, 18, 21, and 24.)
  • FVC as the percentage of the predicted value (FVC%)(Change from baseline FVC% at months 6, 12, 18 and 24.)
  • Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)(Change from baseline FEV1/FVC at months 6, 12, 18 and 24.)
  • Diffusing capacity of the lungs for carbon monoxide (DLCO)(Change from baseline DLCO at months 6, 12, 18 and 24.)
  • COPD Assessment Test (CAT)(At months 6, 12, 18 and 24.)

研究者

发起方
Henan University of Traditional Chinese Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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