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Clinical Trials in Italy / NCT07655219
Starting soon Not applicable

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

NCT07655219 · tracked via the Priya Life Science Italy tracker
Sponsor
Liaquat University of Medical & Health Sciences
Phase
Not applicable
Started
2026-06-22
Last updated
2026-06-17

Condition(s) studied

Functional Dysphonia

Investigational drug(s) / intervention(s)

Dispepril® (Pharmextracta S.p.A. Pontenure, Italy)Half-Dose PPI Plus Dispepril®Full-Dose Proton Pump Inhibitor

Dispepril® (Pharmextracta S.p.A. Pontenure, Italy): Dispepril® 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®: Participants 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: Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Post-Prandial Distress Assessed by the Leuven Postprandial Distress Scale (LPDS) Distress Compared to PPIs — 14 days
    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.

Trial sites (4)

FacilityCityRegionStatus
U.O.S.D. Digestive Endoscopy, Interventional and Emergency Unit Montevarchi Italy
University of Rome Tor Vergata Rome Italy
Gastroenterology Centre Salerno Italy
University of Urbino Carlo Bo Urbino Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07655219 on ClinicalTrials.gov ↗ ← All trials in Italy