An Open-Label Study on the Efficacy of Waton Sole Patches Applied on People with Swollen Legs or Feet

Xiao Zhe ； Chun-Fai Yu

《Adaptive Medicine》 4卷2期 (2012/06) Pp. 90-93

https://doi.org/10.4247/AM.2012.ABC029

並列摘要

This open-label, uncontrolled, 8-day study was aimed at assessing the efficacy of Waton sole patches applied on people with swollen legs or feet. Twenty-six volunteer subjects were enrolled, 18 subjects with disease-causing leg swelling (DLS) and 8 with occupation-causing leg swelling (OLS). Every subject was required to apply the sole patch every night on their soles continuously for 8 nights. The sole patch efficacy was evaluated by three assessment methods: the percentage change in Numeric Pain Rating Scale scores (NPRS), relief of swollen level, and Subject Global Impression of Change (SGIC) from baseline to day 8. The results showed that the DLS subjects achieved a 64.9% and 3.0% mean decrease in pain and swollen level from baseline on day 8 respectively, and 88.9% of them considered themselves to have improved in SGIC after the treatment. The OLS subjects achieved a 63.5% and 2.4% mean decrease in pain and swelling level from baseline on day 8 respectively, and 75.0% of them expressed 'improved' in SGIC. In addition, 80.8% of all subjects reflected a decrease of ＞60% and ＞1.5% in NPRS scores and a relief of swollen level respectively from baseline on day 8.There was no application-site related burning or pain reported from all the subjects. In conclusion, Waton sole patches were found to be safe to use and they reduced pain and swollen level over an 8-day period in subjects with swollen legs or feet.

並列關鍵字

Waton sole patches ； disease-causing leg swelling ； occupation-causing leg swelling