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

NCT06134063 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

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

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06134063 on ClinicalTrials.gov