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

Overview

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.

This is a prospective, multicenter, randomized, controlled clinical trial designed to evaluate the safety and clinical efficacy of Mirgeal® Gel as an add-on to proton pump inhibitor therapy in adult patients with non-erosive gastroesophageal reflux disease (NERD). The study is designed to evaluate the superiority in clinical efficacy of the combination of esomeprazole plus Mirgeal® Gel compared with esomeprazole alone. Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.) is a dietary supplement in stick form containing sodium alginate and standardized derivatives of Glycyrrhiza glabra and Vaccinium myrtillus. Participants will be randomly allocated in a 1:1 ratio to one of two treatment groups. The intervention group will receive esomeprazole 20 mg/day plus Mirgeal® Gel at a dose of 2 sticks per day, with 1 stick taken after lunch and 1 stick after dinner. The control group will receive esomeprazole 20 mg/day alone. Treatment will continue for 4 continuous weeks. Treatment will begin following the baseline assessment. Clinical visits will be conducted at baseline and after 2 and 4 weeks of treatment. Participants will be monitored throughout the study for clinical outcomes, safety and treatment adherence. The total duration of participation for each subject will be 4 weeks, with no post-treatment follow-up period.