An observational study in Chronic Obstructive Pulmoriary Disease (COPD) and Preserved Ratio Impaired Spirometry (PRISM), sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Henan University of Traditional Chinese Medicine · Observational
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.
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.
617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 294 across 216 observational studies indexed under Respiratory Tract Diseases.
Browse Respiratory Tract Diseases studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 52 studies on the registry; 29 are open to participants now.
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Chronic Obstructive Pulmonary Disease (COPD) is a major disease that poses a serious threat to public health, with a prevalence rate of 13.7% in China for people aged 40 years and older, and a prevalence rate of 20.51% in high-risk groups, with a prevalence rate of COPD in high-risk groups of 33.39%, Early screening and identification are of great significance in delaying the progression of lung function and reducing the incidence of COPD. At the same time, patients with COPD are often comorbid with other diseases, and comorbidities have a significant impact on disease progression, consultation, hospitalization, morbidity and mortality, requiring more standardized and systematic recommendations to guide clinical practice.
Exclusion Criteria:
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).
Drug: traditional Chinese medicine (TCM)
Other patients who did not fit into the TCM group.
Drug: non traditional Chinese medicine (non-TCM)
Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).
Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).
Frequencies of acute exacerbations (AEs)
The frequencies of acute exacerbations (AEs) will be recorded.
Time frame: Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.
Incidence of COPD
The incidence of COPD will be recorded.
Time frame: 24 months after enrollment.
6 Six Minute Walk Distance (6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Time frame: 6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.
Traditional Chinese medicine syndromes
The Traditional Chinese medicine syndromes will be recorded.
Time frame: The Traditional Chinese medicine syndromes at months 3, 6, 9, 12, 15, 18, 21, and 24.
Forced expiratory volume in one second (FEV1)
FEV1 will be applied to assess pulmonary function.
Time frame: Change from baseline FEV1 at months 6, 12, 18 and 24.
Forced vital capacity (FVC)
FVC will be applied to assess pulmonary function.
Time frame: Change from baseline FVC at months 6, 12, 18 and 24.
FVC as the percentage of the predicted value (FVC%)
FVC% will be applied to assess pulmonary function.
Time frame: Change from baseline FVC% at months 6, 12, 18 and 24.
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
FEV1/FVC will be applied to assess pulmonary function.
Time frame: Change from baseline FEV1/FVC at months 6, 12, 18 and 24.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
DLCO will be applied to assess pulmonary function.
Time frame: Change from baseline DLCO at months 6, 12, 18 and 24.
COPD Assessment Test (CAT)
CAT will be applied to assess quality of life.
Time frame: At months 6, 12, 18 and 24.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Henan University of Traditional Chinese Medicine