Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.
Taking PRISM patients with impaired lung function at the early stage of COPD retention ratio as the research object, and aiming at the key problems such as the lack of prevention and treatment plan, a two-year randomized double-blind placebo controlled clinical study of Bufei Fang was carried out to establish the early stage TCM prevention and treatment plan to reduce the incidence rate of COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,100
Bufei Recipe: Roasted Astragalus, Codonopsis pilosula, Walnut kernels, Sichuan Fritillaria, Angelica sinensis, Stir fried Purple Su Zi, Honey Baibu, Roasted Purple Aster, etc. Take 1 dose daily, 5 days a week.
The placebo was prepared using 5% of the drug, with color, odor, taste, appearance, and weight similar to the experimental group drug, and packaging consistent with the experimental group drug.
Incidence rate of COPD
Incidence rate of COPD
Time frame: Change from baseline in the number of people with COPD at month 24.
FVC
Forced Vital Capacity (FVC) was mainly used for lung function evaluation
Time frame: Change from baseline in FVC at months 12 and 24.
FEV1
Forced Expiratory Volume in One Second (FEV1) was mainly used for lung function evaluation
Time frame: Change from baseline in FEV1 at months 12 and 24.
FEV1% pred
Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) was mainly used for lung function evaluation
Time frame: Change from baseline in FEV1% pred at months 12 and 24.
FEV1/FVC
Forced Expiratory Volume in One Second / Forced Vital Capacity (FEV1/FVC) was mainly used for lung function evaluation
Time frame: Change from baseline in FEV1/FVC at months 12 and 24.
IPAG-Q
International Primary Airway Health Organization Questionnaire (IPAG-Q) was mainly used for chronic obstructive pulmonary screening score evaluation.
Time frame: Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.
LFQ
Lung Function Questionnaire (LFQ) was mainly used for chronic obstructive pulmonary screening score evaluation.
Time frame: Change from baseline in LFQ score at months 6, 12, 18, and 24.
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COPD-PS
Chronic Obstructive Pulmonary Disease Population Screening Questionnaire (COPD-PS) was mainly used for chronic obstructive pulmonary screening score evaluation.
Time frame: Change from baseline in COPD-PS score at months 6, 12, 18, and 24.
CAT
Chronic Obstructive Pulmonary Disease Assessment (CAT) was mainly used for quality of life evaluation.
Time frame: Change from baseline in CAT score at months 6, 12, 18, and 24.
SF-36
Health Survey Brief (SF-36) was mainly used for quality of life evaluation.
Time frame: Change from baseline in SF-36 score at months 6, 12, 18, and 24.
Clinical symptoms
The assessment will be done through a clinical symptom assessment questionnaire. Clinical symptoms assessed in this study include cough, sputum, wheezing, chest tightness, shortness of breath, malaise and cyanosis. Each symptom or sign will receive a score of 0-3, with higher scores indicating greater severity of the condition.
Time frame: Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.
Biochemical indicators
Serum levels of TNF- α, IL-1, IL-6, immunoglobulin and renal connexin, prolyl peptidase, heme oxygenase-1, superoxide dismutase, glutathione peroxidase and angiotensin-converting enzyme were measured. All indicators were measured in ng/ml.
Time frame: Change from baseline in biochemical indicators at month 12 and 24.