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Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
Sponsor: Liaquat University of Medical & Health Sciences
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.
Official title: Effect of the Use of Alginate Combined With Licorice and Blueberry in the Symptomatic Treatment of Adult Patients With Gastroesophageal Reflux Disease
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-09-07
Completion Date
2027-01-29
Last Updated
2026-08-27
Healthy Volunteers
No
Interventions
Esomeprazole 20mg
Esomeprazole 20 mg administered orally once daily for 4 weeks.
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.
Locations (2)
Casa di Cura Quisisana
Rome, Lazio, Italy
Centro per la Gastroenterologia
Mercato San Severino, Salerno, Italy