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Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure: A Randomized, Double-blind, Placebo Controlled Trial

Clinical Trial Summary

This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life and forming high quality evidence.

Clinical Trial Description

COPD is a highly prevalent disease, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. COPD complicated by CRF is serious and has a high mortality rate. At present, ideal and effective treatment is inadequate. Traditional Chinese medicine (TCM) has some potential in improving outcomes in COPD with CRF.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Yiqi Huoxue Huatan granule on reducing mortality and improving quality of life in COPD with CRF. After a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. The primary outcomes are all-cause mortality and frequency of acute exacerbation of COPD. The secondary outcomes include clinical symptoms, COPD assessment test (CAT), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. Safety will also be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04208581
Study type Interventional
Source Peking University People's Hospital
Contact
Status Enrolling by invitation
Phase Phase 3
Start date October 8, 2019
Completion date December 2021
View Details
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