This multicenter, prospective, randomized, controlled clinical trial aims to evaluate the efficacy of a nutraceutical treatment containing highly standardized extracts of ginger (Zingiber officinale) and perilla (Perilla frutescens) (Dispepril®, Pharmextracta S.p.A. Pontenure, Italy) in improving gastric and intestinal symptoms in adults with functional dyspepsia. The study will assess the non-inferiority of Dispepril® compared with standard proton pump inhibitor (PPI) therapy in reducing postprandial distress symptoms. Participants will be randomized in a 2:1:1 ratio to receive Dispepril® alone, Dispepril® plus half-dose PPI, or full-dose PPI for 14 days. Efficacy will be assessed using the Leuven Postprandial Distress Scale (LPDS), together with evaluations of treatment tolerability, adherence, and adverse events.
Male or female participants aged 18 to 65 years
Diagnosis of functional dyspepsia according to Rome IV criteria
Willingness and ability to provide written informed consent
Ability to follow study product administration instructions
Gastrectomy
Cancer
Use of NSAIDs, cholagogues, or tricyclic antidepressants within 30 days prior to enrollment
Helicobacter pylori positivity
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator