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Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease

NCT07790549 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-08-27

No results posted yet for this study

Summary

Gastroesophageal reflux disease (GERD) is a common condition that can cause symptoms including heartburn, acid regurgitation, sour taste and other upper gastrointestinal complaints. This prospective, multicenter, randomized, controlled, non-profit clinical trial will evaluate the clinical efficacy and safety of Mirgeal® Gel, a dietary supplement containing sodium alginate and standardized extracts of licorice (Glycyrrhiza glabra) and blueberry (Vaccinium myrtillus), when used as an add-on to esomeprazole in adults with non-erosive gastroesophageal reflux disease (NERD).

A total of 140 participants will be randomly assigned in a 1:1 ratio to receive either esomeprazole 20 mg/day plus Mirgeal® Gel, 2 sticks per day (1 after lunch and 1 after dinner), or esomeprazole 20 mg/day alone for 4 continuous weeks. Clinical assessments will be performed at baseline and after 2 and 4 weeks of treatment. The study will assess whether adding Mirgeal® Gel to standard proton pump inhibitor therapy improves reflux-related symptoms and quality of life compared with esomeprazole alone.

Conditions

  • Non-Erosive Gastroesophageal Reflux Disease (NERD)

Interventions

DRUG

Esomeprazole 20mg

Esomeprazole 20 mg administered orally once daily for 4 weeks.

DIETARY_SUPPLEMENT

Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)

Mirgeal Gel administered orally at a dose of 2 sticks daily (1 stick after lunch and 1 stick after dinner) for 4 weeks.

Sponsors & Collaborators

  • University of Urbino "Carlo Bo"

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-07
Primary Completion
2027-01-29
Completion
2027-01-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790549 on ClinicalTrials.gov