chronic obstructive pulmonary disease
Conditions
Interventions
Control group:Zhichuanling Oral Liquid Placebo
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age ranging from 40 to 75 years old (including the terminal value), gender not limited; (2) Meet the diagnostic criteria for acute exacerbation of COPD and be able to provide a pulmonary function test report of the stable period of COPD within one year before enrollment; (3) Pulmonary function classification: GOLD grade II to III; (4) Those who have entered the acute exacerbation stage for no more than 3 days and have not received treatment or standardized treatment, and require outpatient treatment, and have not been clinically determined to have respiratory failure; (5) The severity of AECOPD was evaluated as mild (with the addition of short-acting bronchodilators alone) or moderate (with the addition of short-acting bronchodilators and antibiotics, with or without the addition of oral glucocorticoids). (6) The subjects gave informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those clinically diagnosed with respiratory failure or having severe acidosis (PH=7.35, PaCO2=55mmHg), or in critical condition requiring mechanical ventilation, or needing to be admitted to the ICU for treatment; (2) Complicated with pneumonia, active pulmonary tuberculosis, bronchial asthma, atelectasis, interstitial lung diseases, pneumothorax, pleural effusion, congestive heart failure, arrhythmia, pulmonary embolism, tumors (such as lung cancer), rheumatism or autoimmune diseases, etc. (3) Those who have undergone segmentectomy, wedge resection or field resection of the lung, total pneumonectomy or lung volume reduction surgery due to COPD; (4) Those with other serious diseases of the heart, brain, liver, kidneys, immune system, endocrine system, blood system, etc., among which the blood ALT and AST levels are greater than 1.5 times the upper limit of the normal value, and the blood creatinine (Cr) level is greater than the upper limit of the normal value; (5) Patients with severe benign prostatic hyperplasia, urinary retention or glaucoma; (6) Women who are preparing for pregnancy, pregnant or breastfeeding; (7) Those who are suspected of or have a history of alcohol or drug abuse, or suffer from mental illness; (8) Those who are known to be allergic to the components of the test drug or have an allergic constitution; (9) Those who have participated in or are currently participating in other clinical trials within one month prior to screening; (10) Those who are deemed unsuitable to participate in this clinical trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The duration during which the decrease in E-RS scale scores was equal to or greater than 3 points in both groups after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The duration during which the decrease in E-RS scale scores was equal to or greater than 3 points in both groups after treatment;The daily decrease in the EXACT scale after treatment compared to the baseline value;The change values of the modified British Medical Research Council questionnaire (mMRC) per day after treatment;The change values of the Daily Cough and Sputum Assessment Questionnaire (CASA-Q) after treatment;The change value of 6-minute walking distance (6MWD) before and after treatment;The number and incidence of acute attacks within 28 days;Failure rate of treatment and dropout rate;The proportion of using emergency medications (SABA) and expectorant drugs; | — |
Countries
China
Contacts
Public ContactGao Yi
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed