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
Parallel
Dispepril® (Pharmextracta S.p.A. Pontenure, Italy)
Dietary supplementDispepril® is a gastro-protected dietary supplement containing 300 mg of highly standardized Zingiber officinale extract titrated to 10% gingerols and shogaols and 150 mg of a patented bi-fractionated Perilla frutescens extract per tablet.
Half-Dose PPI Plus Dispepril®
Combination productParticipants will receive a half-dose proton pump inhibitor once daily together with Dispepril® administered as two gastro-protected tablets daily for 14 consecutive days.
Full-Dose Proton Pump Inhibitor
DrugParticipants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.
Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs
Change in post-prandial distress from baseline to Day 14, assessed using the validated Leuven Postprandial Distress Scale (LPDS). The LPDS consists of 8 items assessing postprandial fullness, early satiety, upper abdominal bloating, epigastric pain, epigastric burning, belching, nausea, and heartburn. Each item is rated on a scale from 0 to 4, where 0 indicates no symptom and 4 indicates a very severe symptom. The LPDS has a maximum total score of 32 points.
Change in Individual Gastrointestinal Symptoms Assessed by the Leuven Postprandial Distress Scale
Change from baseline to Day 14 in the individual symptom scores assessed using the Leuven Postprandial Distress Scale (LPDS). The LPDS consists of 8 items evaluating postprandial fullness, early satiety, upper abdominal bloating, epigastric pain, epigastric burning, belching, nausea, and heartburn. Each item is scored from 0 to 4, where 0 indicates no symptom and 4 indicates a very severe symptom. Individual symptom scores range from 0 to 4, with higher scores indicating more severe symptoms and worse outcomes. Changes in individual symptom scores will be compared among treatment groups.
Evaluation of the Efficacy of Treatments on Individual Gastrointestinal Symptoms
Efficacy of treatments in the various study groups on the individual items of gastrointestinal symptomatology of the Leuven Postprandial Distress Scale (LPDS), assessed at the beginning and end of treatment.
Treatment Tolerability Assessed by Investigator Clinical Evaluation
Treatment tolerability at Day 14 as assessed by the investigator during the final clinical evaluation. The outcome will be reported as the number and percentage of participants considered to have tolerated treatment without clinically significant safety concerns.
Therapeutic Adherence
Therapeutic adherence will be assessed at Day 14 by counting returned unused tablets and comparing the number of tablets taken with the number prescribed. The outcome will be reported as the percentage of prescribed tablets taken during the 14-day treatment period.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
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