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
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.
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.
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