A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial. This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment. If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.
• Aged between 40 and 80 years old, including 40 and 80 years old, regardless of gender;
• Clinical records of traceable of the chronic obstructive pulmonary disease history records, after bronchodilator FEV1 less than 80% of the expected value;
• Comply with the definition of COPD acute exacerbations and with mild and moderate severity assessment;
• Symptoms of AECOPD time less than 48 h;
• Shiduyufei diagnostic standard;
• Volunteered for the study, signed informed consent, is willing to cooperate with the visitor.