Effects of dangguijakyaksan on lower-extremity blood circulation disturbances in climacteric and postmenopausal women: Study protocol for a randomized, double-blind, placebo-controlled pilot trial

Background: Climacteric women experience various disorders, including hot flush, depression, insomnia, arthralgia, and hand and foot numbness. Dangguijakyaksan is among the most common treatments for climacteric syndrome, and its effect on depression, insomnia, hot flush and quality of life (QOL) in climacteric women has been reported multiple times. A recent animal study found dangguijakyaksan decreased serum lipid factors and improved blood circulation in a menopausal rat model; however, these effects have not been assessed in clinical trials. This study aims to assess the clinical effects and safety of dangguijakyaksan for lower-extremity blood circulation disturbances in climacteric women.