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 | Not Yet Recruiting DMC

• 1 other identifier: 170_31marzo 2026_DISPEPRIL
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Functional Dysphonia

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (5)

• Change in Individual Gastrointestinal Symptoms Assessed by the Leuven Postprandial Distress Scale

  14 days

• Evaluation of the Efficacy of Treatments on Individual Gastrointestinal Symptoms

  14 days

• Treatment Tolerability Assessed by Investigator Clinical Evaluation

  14 days

• Therapeutic Adherence

  14 days

• Incidence of Treatment-Emergent Adverse Events

  14 days

Study Arms (3)

Dispepril®

EXPERIMENTAL

Participants will receive Dispepril®, administered as two gastro-protected tablets daily for 14 consecutive days. One tablet will be taken approximately 15 minutes before lunch and one tablet approximately 15 minutes before dinner. Each tablet contains 300 mg of highly standardized Zingiber officinale extract and 150 mg of a patented bi-fractionated Perilla frutescens extract.

Dietary Supplement: Dispepril® (Pharmextracta S.p.A. Pontenure, Italy)

Half-Dose PPI Plus Dispepril®

EXPERIMENTAL

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. One tablet will be taken approximately 15 minutes before lunch and one tablet approximately 15 minutes before dinner.

Combination Product: Half-Dose PPI Plus Dispepril®

Full-Dose PPI

ACTIVE COMPARATOR

Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.

Drug: Full-Dose Proton Pump Inhibitor

Interventions

Dispepril® (Pharmextracta S.p.A. Pontenure, Italy) DIETARY_SUPPLEMENT

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.

Also known as: Ginger Extract, Perilla Extract

Dispepril®

Half-Dose PPI Plus Dispepril® COMBINATION_PRODUCT

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.

Also known as: PPI + Dispepril®

Half-Dose PPI Plus Dispepril®

Full-Dose Proton Pump Inhibitor DRUG

Participants will receive a full-dose proton pump inhibitor once daily for 14 consecutive days according to standard clinical practice for functional dyspepsia.

Also known as: Full-Dose PPI

Full-Dose PPI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (4)

U.O.S.D. Digestive Endoscopy, Interventional and Emergency Unit

Montevarchi, Italy

Location

University of Rome Tor Vergata

Rome, Italy

Location

Gastroenterology Centre

Salerno, Italy

Location

University of Urbino Carlo Bo

Urbino, Italy

Location

MeSH Terms

Interventions

ginger extract

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and investigators are aware of the assigned intervention. Outcome assessments are performed using the Leuven Postprandial Distress Scale (LPDS).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Participants will be randomized in a 2:1:1 ratio to one of three parallel treatment groups: Dispepril® alone, Dispepril® plus half-dose proton pump inhibitor (PPI), or full-dose PPI. Participants will remain in their assigned treatment group throughout the 14-day treatment period.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)