chronic obstructive pulmonary disease
Conditions
Interventions
Test group:Lianhua Qingke Tablets+Basic Treatment, Usage: Lianhua Qingke Tablets, 4 tablets/time, 3 times/day
Placebo control group:Lianhua Qingke Tablet placebo+basic treatment, usage: Lianhua Qingke Tablet placebo, 4 tablets/time, 3 times/day
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 40-80 years old (including both ends); 2. Complies with the COPD diagnostic criteria established by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD 2023) and the Respiratory Disease Society of the Chinese Medical Association: reports of lung function diagnosis in the past year, i.e. FEV1/FVC= 6 points; 5. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Concurrent respiratory failure requiring endotracheal intubation and non-invasive or invasive mechanical ventilation; 2. Patients with acute exacerbation requiring intravenous use of antibiotics; 3. Those who have taken oral or intravenous corticosteroids within one month prior to enrollment; 4. Patients with bronchiectasis accompanied by hemoptysis, or those with obvious bronchiectasis on imaging; 5. The patient was complicated with other active lung diseases before enrollment, such as active tuberculosis, lung cancer, pulmonary embolism, sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchial asthma and pulmonary inflammation. Alternatively, patients with concurrent pneumothorax, pleural effusion, and pulmonary encephalopathy; 6. Abnormal liver function (ALT or AST exceeding 2 times the upper limit of normal), abnormal kidney function (blood creatinine exceeding 1.5 times the upper limit of normal); 7. Serious primary diseases of important organ systems, such as acute stroke, hypertension above moderate level after treatment, active gastric ulcer, diabetes (serious complications), malignant tumors, etc; 8. History of severe heart disease, such as acute myocardial infarction, congestive heart failure (NYHA class III or above), severe arrhythmia, and other acute heart diseases; 9. Participated in other clinical trials within 4 weeks prior to enrollment; 10. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period, or women who are capable of reproduction but have not used effective contraception methods (women of childbearing age need to undergo urine or blood pregnancy tests); 11. Those who do not comply or cooperate, cannot correctly describe their own illness or conduct corresponding respiratory questionnaire surveys; 12. Those who are allergic to the ingredients of Lianhua Qingke tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in breathing difficulties, cough, and sputum scale (BCSS) scores from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in cough severity scale (CET) score from baseline;Changes from baseline in the modified version of the Medical Research Council (mMRC) score in the UK;Changes in Chronic Obstructive Pulmonary Disease (COPD) Patient Assessment Test (CAT) Score from Baseline;Changes in lung function (FEV1, FVC, FEV1/FVC) from baseline;Changes in inflammatory factors (IL-1 a, IL-1 ß, IL-4, IL-6, IL-8, TNF - a, and IFN - ?) and aging factor (NAD+) compared to baseline;The proportion of severe cases. (Due to worsening symptoms of acute exacerbation of chronic obstructive pulmonary disease or other reasons requiring treatment upgrade); | — |
Countries
China
Contacts
Public ContactSong Yuanlin
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed