Assessment of the Efficacy of a Highly Standardized Ginger and Perilla Nutraceutical (Dispepril®) in Improving Gastric and Intestinal Symptoms in Patients With Functional Dyspepsia

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.

Inclusion Criteria: * 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 * Ability to attend scheduled study visits Exclusion Criteria: * Gastrectomy * Cancer * Use of NSAIDs, cholagogues, or tricyclic antidepressants within 30 days prior to enrollment * Helicobacter pylori positivity * Alcoholism or other substance abuse * Hepatic disease * Renal disease * History of hypersensitivity to formulation active ingredients or excipients * Pregnancy or breastfeeding * Participation in another clinical trial or completion of another clinical trial within 1 month prior to enrollment * Refusal or inability to provide informed consent