Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577701
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Respiratory Disease Cohort Studies of Chinese Medicine for COPDRESEARCH-COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Respiratory Disease Cohort Studies of Chinese Medicine for Chronic Obstructive Pulmoriary Disease RESEARCH-COPD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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 people39s health The prevalence of COPD among people aged 40 and above in China is 137 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None