An interventional study of Esomeprazole 20mg and Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.) in Non-Erosive Gastroesophageal Reflux Disease (NERD), sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting at 2 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Treatment
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 140 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive esomeprazole 20 mg/day plus Mirgeal® Gel, 2 sticks daily (1 stick after lunch and 1 stick after dinner), for 4 weeks.
Drug: Esomeprazole 20mg · Dietary Supplement: Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)
Participants will receive esomeprazole 20 mg/day alone for 4 weeks.
Drug: Esomeprazole 20mg
Esomeprazole 20 mg administered orally once daily for 4 weeks.
Mirgeal Gel administered orally at a dose of 2 sticks daily (1 stick after lunch and 1 stick after dinner) for 4 weeks.
Change in GERD-Related Quality of Life Assessed by GERD-HRQL
Change in gastroesophageal reflux disease symptoms and their impact on quality of life will be assessed using the validated Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire. The questionnaire includes 10 items scored from 0 (no problem) to 5 (severe problem), with higher scores indicating greater symptom burden. GERD-HRQL will be administered at baseline, Week 2, and Week 4.
Time frame: Baseline, Week 2, and Week 4
Change in Reflux Symptoms Assessed by the Reflux Symptom Index (RSI)
Change in reflux-related symptoms will be assessed using the Reflux Symptom Index (RSI). The RSI evaluates nine reflux-related symptoms, with each item scored from 0 (no problem) to 5 (severe problem). The total score ranges from 0 to 45, with higher scores indicating greater symptom severity.
Time frame: Baseline, Week 2, and Week 4
Change in Gastroesophageal Reflux Symptom Intensity Assessed by 0-10 Visual Analog Scale
Change from baseline in the intensity of regurgitation, heartburn, and sour taste in the mouth, assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no symptoms and 10 indicates the worst possible symptom. Higher scores indicate greater symptom severity. Assessments will be performed at baseline, Week 2, and Week 4.
Time frame: Baseline, Week 2, and Week 4
Investigator Global Assessment of Performance (IGAP) Rating of Treatment Effectiveness
At Week 4, the investigator will assess overall treatment effectiveness using the Investigator Global Assessment of Performance (IGAP), based on the participant's overall clinical evaluation, including patient-reported symptoms, completed questionnaires, and use of rescue medications. Treatment effectiveness will be rated from poor to excellent, with higher ratings indicating better treatment performance.
Time frame: Week 4
Participant-Rated Palatability of Mirgeal® Gel Using the Study Palatability Questionnaire
Participants assigned to Mirgeal® Gel will assess the palatability of the study product at Week 4 using the study palatability questionnaire. Participants will provide an overall rating ranging from bad to excellent, with higher ratings indicating better palatability.
Time frame: Week 4
Incidence of Adverse Events
Safety and tolerability will be assessed by recording adverse events reported by participants during the study. Adverse events will be documented throughout the treatment period.
Time frame: From baseline through Week 4
Percentage Treatment Adherence Assessed on a 0-100% Scale
Treatment adherence will be assessed at Week 4 and reported as a percentage from 0% to 100%, with higher percentages indicating greater adherence to the assigned treatment regimen. Adherence will also be assessed through return of unused Mirgeal® Gel packs or sticks, as applicable.
Time frame: Week 4
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Liaquat University of Medical & Health Sciences