Chronic obstructive pulmonary disease
Conditions
Interventions
Experimental group:Yupingfeng granules (5 g/sachet, 1 sachet each time, 3 times a day, oral administration)
Control group:Yupingfeng granule simulating agent (5g/bag, 1 bag each time, 3 times a day, oral administration)
Experimental group:Clinical routine treatment
3142
Sponsors
The First Affiliate Hospital of GUANGZHOU Medical
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 40 years old= age = 80 years old; 2. Meet the diagnostic criteria of COPD (chronic obstructive pulmonary disease); 3. In the clinical symptom score, the single score of sputum cough = 1 point; 4. In patients diagnosed with moderate to severe COPD according to the 2021 gold guidelines, FEV1/FVC = 70% after bronchodilator therapy, 30% = FEV1 accounted for 80% of the predicted value after bronchodilator use<80%; 5. 2 moderate acute exacerbations occurred in the = year before the admission, or 1 severe acute exacerbation = or 1 hospitalization due to acute exacerbations; 6. In a stable stage, no respiratory infections and acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in the 4 weeks before screening; 7. Subjects voluntarily join the study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Before enlistment, the diagnosis time of COPD is less than 12 months; 2. Require daily oxygen therapy; 3. Respiratory tract infection and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) occurring within 4 weeks before screening or during screening; 4. Live attenuated vaccines were given within 4 weeks prior to enrolment, or live attenuated vaccines were planned for the duration of the study; 5. Plan to perform pneumonectomy or lung volume reduction or have a history of such surgery. Patients participating in the acute phase of the pulmonary rehabilitation program, that is, patients who began rehabilitation within 4 weeks prior to screening; 6. Patients currently diagnosed with asthma or have a history of asthma in accordance with the 2018 Global Asthma Initiative (GINA) guidelines or other recognized guidelines; 7. Co-existing major lung diseases other than COPD (such as interstitial fibrosis, active tuberculosis, pulmonary resection, lung tumors, etc.); 8. Concomitantly suffering from severe heart system diseases (congestive heart failure, grade III. to IV. according to NYHA classification severity; significant arrhythmias or heart valve abnormalities affecting hemodynamic conditions; history of unstable angina or myocardial infarction in the past 6 months); 9. Poor control of insulin-dependent diabetes mellitus (HBA1c=8.0%); Clinically significant laboratory tests (e.g., ALT>5ULN, AST>5ULN, or Scr>1.5ULN); 10. Immunodeficient patients (such as: organ or bone marrow transplanters, AIDS patients, those who take immunosuppressive drugs within 3 months before screening examinations); 11. Previously severe neurological, hematologic, gastrointestinal, cerebrovascular diseases, and a history of substance abuse and/or alcohol abuse, malignancy or active malignancy (except for cervical carcinoma in situ, non-metastatic squamous cell carcinoma of the skin, or cutaneous basal cell carcinoma) within the first 5 years of the baseline, and current or previous major diseases that the researcher determines may interfere with the study or require treatment that may interfere with the study; 12. Screening patients who often take Cordyceps health products and proprietary Chinese medicines containing astragalus and other tonic effects in the first 3 months, or who the researchers deem unsuitable to participate in this study; 13. Those who are known to be allergic to the ingredients contained in the research drugs, or patients with allergic constitutions; 14. Women who are breastfeeding or pregnant, or women of childbearing age who plan to become pregnant within 6 months after screening tests, or those who have a positive urine pregnancy test; or male patients with fertility or sperm donation plans; 15. Screening of patients who have participated in clinical trials of other drugs within 3 months before the examination; 16. Other patients who the investigator deems unfit to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of COPD Assessment Test (CAT) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause admission rate and acute exacerbation admission rate during the 52 week treatment period;Changes in individual clinical symptom scores;Changes in total clinical symptom scores;Duration and interval of acute exacerbation during 52 weeks of treatment;Frequency of use of first aid drugs;Change of SGRQ total score;Proportion of patients whose total SGRQ score improved by = 4 at week 52;Changes of COPD Assessment Test (CAT) Score;Annual rate of acute exacerbation of moderate or severe COPD during 52 weeks of treatment;Annualized rates of acute exacerbations of COPD by severity during 52 weeks of treatment;The first time of severe or moderate exacerbation of COPD occurred during 52 weeks of acute or moderate exacerbation of COPD; | — |
Countries
The People's Republic of China
Contacts
Public ContactZheng Jinping
Outcome results
None listed