Chronic obstructive pulmonary disease
Conditions
Interventions
Shengqi Yifei formula granule low dose group:Shengqi Yifei formula granule low dose
Standard dose group of Shengqi Yifei formula granules:Standard dose of Shengqi Yifei formula granules
Traditional decoction group:Traditional decoction pieces
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) 40 years old= age = 85 years old, both male and female; (2) meet the diagnostic criteria for COPD as defined by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD, 2023 Edition)[1]; (3) CAT score = 10 points at the time of enrollment; (4) The patient was in a stable period, and there was no acute exacerbation of COPD in the 4 weeks before the screening period; (5) During the screening period to the start of randomized treatment, there was no acute exacerbation of COPD; (6) No acute respiratory infection occurred within 4 weeks before enrollment; (7) TCM syndrome differentiation is qi deficiency and phlegm stasis syndrome; (8) The patient is informed and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Complicated with bronchial asthma, bronchiectasis, interstitial lung disease, obstructive sleep apnea syndrome, lung malignant tumor, active tuberculosis and other diseases; 2: Previous pneumonectomy or lung volume reduction surgery within 12 months before screening; 3: Patients with serious cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases, digestive tract diseases, blood system diseases, etc., or patients with serious basic diseases such as malignant tumors, low immune function and nervous system disorders; 4: Accompanied by abnormal liver function [ALT or AST=1.5 ULN(upper limits of normal) or abnormal renal function (serum creatinine =1.5 ULN); 5: Use ltot (oxygen therapy time > 15h/d) or home noninvasive ventilation; 6: Long-term use of traditional Chinese medicine diet (such as Radix Astragali, Rhizoma Cimicifugae, Radix Codonopsis and other Chinese herbal medicines) for conditioning patients; 7: Have a history of allergy or hypersensitivity to the ingredients of the study drug, or have diseases that the researcher thinks should be prohibited from using the study drug; 8: Poor compliance, patients with mental illness or those who cannot cooperate for other reasons; 9: Patients who are participating in or preparing to participate in other clinical trials during the study; 10: Pregnant, planned pregnancy or lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic obstructive pulmonary disease assessment test (CAT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified British Medical Research Council Questionnaire (mMRC);St George's Breathing Questionnaire (SGRQ);6-minute walking distance (6MWT);Incidence of acute exacerbation;Acute aggravated admission rate;Per capita acute exacerbation frequency;Cough and expectoration assessment questionnaire (CASA-Q); | — |
Countries
China
Contacts
Public ContactYuanbin Chen
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed