"Efficacy and safety of the Qiguiyin formula in severe pneumonia: study protocol for a randomized, double-blind, placebo-controlled clinical trial".

"Efficacy and safety of the Qiguiyin formula in severe pneumonia: study protocol for a randomized, double-blind, placebo-controlled clinical trial". J Tradit Chin Med. 2020 Apr;40(2):317-323 Authors: Huang P, Guo Y, Wu Y, Liu Q, Zhao J, Li B Abstract OBJECTIVE: To evaluate the clinical efficacy and safety of Qiguiyin (QGY) formula in patients with severe pneumonia in China compared with a placebo. METHODS: This is a multicenter double-blind, placebo-controlled, randomized clinical trial with two parallel arms. There will be 530 patients enrolled and randomized into either the experimental group (QGY formula) or the control group (placebo). Therapies for patients in the two groups above will be based on the conventional therapy. The primary outcome is 28-day mortality. Secondary outcomes include: (a) duration of hospital stay; (b) duration of time in the intensive care unit (ICU) stays; (c) duration of mechanical ventilation; (d) antibiotic DDD value(which means the doses of antibotics during the treatment period); (e) serum procalcitonin (PCT) level; (f) serum C-reactive protein (CRP) level; (g) Pneumonia severity index (PSI) score; (h) Sequential Organ Failure Assessment (SOFA) score; (i) sputum culture results; (j) blood routine examination results; (k) routine urine test results; (l) stool routine examination results; (m) electrocardiogram results; (n) alanine aminotransferase levels; (o) aspartate amino transferase levels...
Source: Journal of Traditional Chinese Medicine - Category: Complementary Medicine Authors: Tags: J Tradit Chin Med Source Type: research