Efficacy and safety of steamed ginger extract for gastric health: a randomized, double-blind, placebo-controlled multi-center clinical trial

The aim of this study was to investigate the efficacy and safety of steamed ginger extract (GGE03) for mild to moderate functional dyspepsia (FD) in a 12-week randomized, double-blind, placebo-controlled clinical trial. A total of 80 subjects who met the inclusion criteria without meeting the exclusion criteria were randomly assigned to a GGE03 group (<i>n</i> = 40, 480 mg day^-1 as GGE03) or a placebo group (<i>n</i> = 40). Efficacy and safety evaluations were conducted before intervention and at 12 weeks after intervention. The GGE03 group showed significantly improved gastrointestinal symptom rating scale (GSRS) total score and sub-scores (abdominal pain, constipation, indigestion, and reflux) compared to the placebo group (<i>p</i> < 0.001 for all). Moreover, the 36-Item Short Form Survey (SF-36) sub-scales (general health, health change, pain, physical functioning, role limitations due to physical health, and social functioning) were significantly improved in the GGE03 group compared to those in the placebo group (<i>p</i> = 0.002, <i>p</i> = 0.016, <i>p</i> = 0.006, <i>p</i> = 0.001, <i>p</i> < 0.001, and <i>p</i> = 0.023, respectively). Safety evaluations (adverse events, complete blood count, blood chemistry, and urinalysis) revealed that GGE03 was safe without causing clinically meaningful changes. Therefore, GGE03 has the potential to be used as a health functional food for improving gastric health.