Objective To assess the efficacy of Chinese herbal medication on quality of life in patients with functional dyspepsia of spleen-deficiency and qi-stagnation syndrome.Methods A randomized, double-blind, placebo-controlled trial were performed in 5 centers.Patients with FD of spleen-deficiency and qi-stagnation syndrome (n =160) were randomly assigned to groups given Chinese herbal medicine (CHM) or placebo in a 2∶1 ratio.Herbal or placebo granules were dissolved in 300 ml of boiled water cooled to 70℃C.Patients in both groups were administered 150 ml (50℃C) twice daily.This trial included a 4-week treatment period and a 4-week follow-up period.The outcome was Chinese (mainland) version of the 36-item Short-Form Health Survey (SF-36), at weeks 0, 4 and 8.