Chronic obstructive pulmonary disease
Conditions
Interventions
Sponsors
Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-80 years old; 2. Patients with mild to moderate COPD: meet the diagnostic criteria of COPD formulated by the global initiative for chronic obstructive pulmonary disease (gold) and the society of respiratory diseases of Chinese Medical Association: there was a previous year's report of pulmonary function diagnosis, that is, FEV1 / FVC was less than 70% after inhalation of bronchodilator; FEV1 accounted for more than 50% of the predicted value; 3. Patients who meet the diagnostic criteria of acute stage of chronic obstructive pulmonary disease (AECOPD): compared with the stable stage, the patients' condition continues to worsen, exceeding the normal changes during the day, that is, the patients with COPD are acute onset, and need to adjust the routine medication; 4. Patients with fever, cough, yellow cough, purulent phlegm and other clinical manifestations; 5. The imaging examination is consistent with the manifestations of chronic bronchitis and emphysema, or with pulmonary exudation shadow. Patients with pulmonary tuberculosis, pulmonary tumor, pulmonary embolism, interstitial lung disease and pulmonary edema were excluded; 6. Subjects who fully understood and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to the ingredients and excipients of the test drug; 2. Patients with bronchial asthma, bronchiectasis, pulmonary fibrosis, pulmonary hypertension, severe pulmonary infection, acute exacerbation of severe chronic obstructive pulmonary disease, tuberculosis, tuberculous pleurisy, respiratory failure, and those requiring ventilator-assisted treatment; 3. Patients who have been or are currently being evaluated in any of the following major disease histories or impact studies: (1) Patients with inability to expectorate (such as long-term bed rest, advanced lung cancer, etc.); (2) Nearly 3 patients had history of cerebrovascular accident, such as ischemic stroke and hemorrhagic stroke; (3) Sick sinus syndrome, degree II-III atrioventricular block, atrial flutter, atrial fibrillation and other malignant or potential malignant arrhythmias; (4) Large aneurysm or dissecting aneurysm, percutaneous transluminal coronary angioplasty or cardiac surgery; (5) Unstable angina, myocardial infarction and heart failure were found in the past 3 months; (6) Patients with severe liver disease or liver dysfunction (such as cirrhosis, chronic active hepatitis, etc.); (7) Patients with severe nephropathy (such as chronic renal insufficiency, renal artery stenosis, etc.); (8) History of malignant tumor; (9) Severe primary disease of hematopoietic system or agranulocytosis. 4. Patients with any laboratory test index meeting the following criteria before enrollment: (1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 1.5 times the upper limit of normal value (ULN) (refer to the range of normal value in the laboratory of the research center); (2) Serum creatinine (CR) is more than 1.5 times the upper limit of normal value (ULN) (refer to the range of normal value in the laboratory of the research center). 5. Other general conditions that are not suitable for the study: (1) Patients who have participated in or are participating in any other clinical trials within 3 months before screening; (2) Patients with previous histories of drug, alcohol or drug abuse; (3) Patients with severe neurological and mental disorders who cannot fully understand and cooperate; (4) Women and men of childbearing age who are pregnant, lactating, planning to be pregnant or who do not take reliable birth control measures are not willing to take birth control methods during the trial period and within 30 days after the last medication. HCG in urine should be checked in women of childbearing age; (5) Patients who are unable to comply with the requirements of the study protocol; (6) Other situations that the researchers think are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspnea, cough and expectoration scale;TCM clinical syndrome index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function;Sputum culture;Routine blood test; | — |
Countries
China
Contacts
Public ContactXu Guihua
Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Outcome results
None listed