Clinical Research Directory
Browse clinical research sites, groups, and studies.
Assessment of the Efficacy of a Highly Standardized Ginger and Perilla Nutraceutical (Dispepril®) in Improving Gastric and Intestinal Symptoms in Patients With Functional Dyspepsia
Sponsor: Liaquat University of Medical & Health Sciences
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.
Official title: Assessment of the Efficacy of a Highly Standardized Ginger and Perilla Nutraceutical (Dispepril®) in Improving Gastric and Intestinal Symptoms in Patients With Functional Dyspepsia: A Multicenter, Randomized, Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-06-22
Completion Date
2026-11-30
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
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