The efficacy and safety of Chinese herbal medicine Shen-Qi Hua-Yu formula in patients with diabetic lower extremity artery disease: Study protocol of a multi-center, randomized, double-blind, placebo-controlled trial

This study is a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of CHM in patients with diabetic LEAD, and to interpret the therapeutic mechanism of Shen-Qi Hua-Yu formula in treatment of diabetic LEAD through proteomics technology, and to screen biomarkers with characteristics of TCM diagnosis and clinical efficacy evaluation. On the other hand, to our knowledge, this study may be the first trial of CHM formulas to observe cardiovascular outcomes through long-term follow-up for the treatment of diabetic LEAD, which is of great value. Trial registration: This study is registered on the Chinese Clinical Trial Registry: ChiCTR1900026372.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Study Protocol Clinical Trial Source Type: research