Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHenan University of Traditional Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
traditional Chinese medicine (TCM)
DrugRegulated 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).
non traditional Chinese medicine (non-TCM)
DrugRegulated 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).
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Traditional Chinese Medicine cohort1 intervention
Group B: Non Traditional Chinese Medicine cohort1 intervention
Trial outcomes
Primary outcomes
1
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 24.2
Incidence of COPD
The incidence of COPD will be recorded.
Time frame
24 months after enrollment.Secondary outcomes
1
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 24.2
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 24.3
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 24.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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