A multicenter, randomized, controlled clinical trial of efficacy and safety of xinan Guben Peiyuan formula series in the treatment of COPD
- Conditions
- Chronic obstructive pulmonary disease
- Registration Number
- ITMCTR2200005834
- Lead Sponsor
- The First Affiliated Hospital of Anhui University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
? Patients who meet the diagnostic criteria for COPD; ? It belongs to stable period; ? It conforms to the TCM syndrome differentiation standard of lung qi deficiency/Lung spleen qi deficiency/lung kidney qi deficiency; ?40 years = age =75 years; ? Did not participate in other clinical studies 3 month before enrollment; ? No antibiotics were used 3 month before enrollment; ? Voluntarily accept treatment, sign informed consent before the test, and fully understand the content, process and possible adverse reactions of the test.
If the answer to any of the following questions is yes, the patient will not be admitted to the study: ? Allergic constitution or allergic to the known ingredients of the test drug or control drug; ? Extremely severe COPD patients and acute stage patients; ? Pregnant and lactation women; ? Delirious, dementia, all kinds of mental patients; ? Functional grade ? and hemodynamic instability; ? With bronchiectasis, bronchial asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pleural effusion, malignant tumor and other neuromuscular diseases affecting respiratory motor function;? Severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose bleeding, serious kidney disease including dialysis, kidney transplantation); ? all kinds of reasons for long-term bed. ? Persons who have participated in other interventional clinical trials within the last 3 months; ? Participants considered unsuitable for the clinical trial by the investigator.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ung function;Acute aggravation severity;Number of acute exacerbations;TCM syndrome integral;Number of colds;
- Secondary Outcome Measures
Name Time Method Dyspnea classification;SF-36 scale;COPD - PRO scale;Self-rating Depression Scale;Self-rating Anxiety Scale;The CAT score;Six minutes' walk;