Chronic obstructive pulmonary disease - acute exacerbation phase
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age 18 and above, gender not limited; (2) Those who meet the diagnostic criteria for AECOPD in the Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Revised in 2023) and have a severity level of AECOPD classified as Grade I or II; (3) Meets the diagnostic criteria for phlegm heat obstructing the lungs in traditional Chinese medicine; (4) Co infected individuals (hs CRP>10mg/L); And 1): worsening of breathing difficulties, increased sputum volume, and purulent sputum, or 2): only two of these symptoms appear, but including purulent sputum. (5) Patients who voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Major lung diseases other than COPD, such as active tuberculosis, fungal infection, tumor, bronchial asthma, bronchiectasis with infection, pulmonary fibrosis and other primary lung diseases; (2) Combined with severe cardiovascular disease (congestive heart failure, classified as NYHA severity level IV); Significant arrhythmias or heart valve abnormalities that affect hemodynamic status; History of unstable angina or myocardial infarction within the past 6 months; (3) For patients with severe primary diseases of the heart, liver, kidney, digestive, and hematopoietic systems, liver function ALT/AST is greater than twice the upper limit of normal, and renal function SCr is greater than the upper limit of normal; (4) Severe ventilation dysfunction requiring invasive mechanical ventilation; (5) Diabetes ketoacidosis, diabetes hyperosmolar coma; (6) Pregnant or lactating women; (7) Individuals with allergic constitution or those who are allergic to known ingredients of this medicine; (8) Patients with mental illness and others who are unable to provide sufficient informed consent due to intellectual or behavioral impairments; (9) Participated in other clinical trials within the previous month prior to screening; (10) The researchers believe that there are other factors that are not suitable for inclusion, or those who are currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Single Symptom Score;pulmonary function;Inflammatory markers (hs CRP);Modified Medical Research Council Dyspnea Scale;6-minute walking test; | — |
Countries
CHINA
Contacts
HUNAN ACADEMY OF CHINESE MEDICINE