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Clinical Trial Summary

The purpose for this study is to determine safety and effectiveness of the oxyhydrogen generator with nebulizer through a therapy for improving symptoms in patients with acute exacerbations of copd.


Clinical Trial Description

In this study, patients with acute exacerbations of copd who were included in both treatment and control groups, administered randomly oxyhydrogen generator with nebulizer (treatment group) or oxygen Nebulizer Machine (control group for the therapy. The therapeutic outcomes in both treatment and control groups are analyzed and evaluated to verify safety and effectiveness of the test product. This study is a multi-center, randomized, double-blind study. The trial lasted for about 10 days. The curative effect was observed for subjects in the First, the second, the third, the fourth, the fifth, the sixth, the seventh day, respectively as the observing time point. Total patients which are planned to be included are 108 cases, where, 54 cases in the treatment group and control group respectively are distributed in 10 clinical hospitals ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04000451
Study type Interventional
Source Shanghai Asclepius Meditec Inc.
Contact
Status Completed
Phase N/A
Start date January 7, 2019
Completion date September 20, 2019

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