Safety and efficacy of Artemisia argyi extract RW0117 for functional dyspepsia: A randomized, double-blind, placebo-controlled clinical study.

Ethnopharmacological Relevance: Artemisia argyi (A. argyi) is a herbaceous perennial plant that has long been employed in traditional medicine for the management of gastrointestinal conditions such as abdominal pain, gastric ulcer, diarrhea, and gastritis.

Aim Of The Study: To evaluate the efficacy and safety of RW0117, an ethanol extract of A. argyi, in alleviating the symptoms of functional dyspepsia (FD).

Materials And Methods: In a randomized, double-blind, placebo-controlled clinical trial, participants were randomly assigned to receive either one tablet of RW0117 (680 mg/day, containing 240 mg of ethanol extract of A. argyi) or one placebo tablet for 12 weeks. The primary outcome was the change from baseline on the gastrointestinal symptom-rating scale (GSRS). Secondary outcomes included changes from baseline in the total GSRS score, gastrointestinal symptoms (GIS), Nepean Dyspepsia Index-Korean version (NDI-K) score, Functional Dyspepsia-related Quality of Life (FD-QoL), and adverse events.

Results: This study showed that five individual symptoms in the upper abdominal GSRS and two symptoms in the lower abdominal GSRS, as well as the total GSRS scores, were improved significantly in the RW0117 group compared to the placebo group. Furthermore, patients receiving RW0117 showed significant improvements in GIS, NDI-K, and FD-QoL scores at the end of treatment compared to the placebo group.

Conclusion: In conclusion, treatment with RW0117 was safe and showed significant potential for reducing FD symptoms.