Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Experimental group:Huashi Baidu granule+ conventional treatment
Control group:Huashi Baidu placebo granule + conventional treatment
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-85 years, no gender limit; 2. The patient meets the diagnostic criteria of 2023 GOLD guidelines and is in the stage of acute exacerbation; 3. According to the 2023 GOLD guidelines, the severity of acute exacerbations was assessed as moderate to severe; 4. Antibiotic indications recommended by the Chinese Expert Consensus on Anti-infective Treatment of Acute exacerbation of Chronic obstructive Pulmonary Disease: (1) The patient has purulent sputum (increased dyspnea, increased sputum volume and purulent sputum at the same time, or only any two symptoms including purulent sputum); (2) Non-invasive ventilation support; 5. The numerical rating score (NRS) of sputum symptom >=4 points; 6. TCM syndrome differentiation belongs to phlegm-heat obstructing lung syndrome; 7. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Complicated with other respiratory diseases, such as lung cancer, bronchial asthma, bronchiectasis, pneumothorax, active pulmonary tuberculosis and other primary pulmonary diseases; 2. Pulmonary embolism is clinically confirmed or highly suspected; 3. Patients with acute COPD exacerbation requiring oral or intravenous glucocorticoid treatment; 4. Patients with severe acute exacerbation of COPD requiring invasive mechanical ventilation or ICU treatment; 5. TCM syndrome differentiation of spleen and stomach deficiency cold; 6. Patients with serious primary diseases of the heart, cerebrovascular and hematopoietic systems or malignant tumors; 7. Patients with severe liver and kidney diseases (cirrhosis, portal hypertension, dialysis, kidney transplantation, etc.) or AST, ALT, Cr > 1.5N (N is the upper limit of normal value); Present with an immune deficiency, such as malignant tumor, organ or bone marrow transplant, HIV infection, or use of immunosuppressant within the last 3 months; 8. History of gastrointestinal diseases associated with dysphagia or significantly affecting drug absorption (including but not limited to chronic diarrhea, Crohn's disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-subtotal gastrectomy, etc.); 9. Patients with diabetes mellitus and unstable blood glucose control within 3 months before the onset of AECOPD, and the control target of glycosylated hemoglobin > 7%; 10. Unable to cooperate or unwilling to cooperate because of neurological or mental illness; 11. Allergic constitution, or known allergic history to Huashui and Jiaodu granules or placebo ingredients, or allergic history to multiple drugs (more than two kinds or known ingredients in the drug); 12. Pregnant and intended pregnant or lactating patients; 13. Participated in other clinical trials within the last 3 months, or took the study drug in the month prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough and sputum assessment questionnaire, CASA-Q; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-assessment test questionnaire for COPD patients, CAT ;Modified version of the British medical research council dyspnea questionnaire, mMRC;Clinical COPD questionnaire, CCQ;Borg dyspnea rating scale;Procalcitonin;C-reactive protein;TCM syndrome score;Numeric ratinf scale score of phlegm;Emergency mitigation drug use; | — |
Countries
China
Contacts
Public ContactLin Lin
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed