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

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmoriary Disease (COPD); Preserved Ratio Impaired Spirometry (PRISM)

Treatments: Drug: traditional Chinese medicine (TCM); Drug: non traditional Chinese medicine (non-TCM)

Study type: Observational

Funder types: Other

Identifiers

NCT06577701

RESEARCH-COPD

Details and patient eligibility

About

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 for COPD prevention and treatment will be established.

Full description

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

10,000 participants in 2 patient groups

Traditional Chinese Medicine cohort

Description:

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).

Treatment:

Drug: traditional Chinese medicine (TCM)

Non Traditional Chinese Medicine cohort

Description:

Other patients who did not fit into the TCM group.

Treatment:

Drug: non traditional Chinese medicine (non-TCM)