NCT06134063

A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Xuanfei Baidu granule	Xuanfei Baidu granule will be administered twice daily for 7 days on the basis of basic treatment
DRUG	Xuanfei Baidu granule Placebo	Xuanfei Baidu granule Placebo will be administered twice daily for 7 days on the basis of basic treatment

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: China