[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653757":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":34,"armGroups":42,"interventions":55,"overallOfficials":34,"centralContacts":66,"locations":72,"responsibleParty":104,"collaborators":108,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":34,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":34,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":34,"overallStatus":130,"whyStopped":34,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline, Week 2, and Week 4",[14,17,20,24,27,31],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":23},"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.","Week 4",{"measure":25,"description":26,"timeFrame":23},"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.",{"measure":28,"description":29,"timeFrame":30},"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.","From baseline through Week 4",{"measure":32,"description":33,"timeFrame":23},"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.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE","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.\n\nMirgeal® 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\u002Fday 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\u002Fday alone. Treatment will continue for 4 continuous weeks.\n\nTreatment 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.",[43,50],{"label":44,"type":45,"description":46,"interventionNames":47},"Esomeprazole Plus Mirgeal® Gel","EXPERIMENTAL","Participants will receive esomeprazole 20 mg\u002Fday plus Mirgeal® Gel, 2 sticks daily (1 stick after lunch and 1 stick after dinner), for 4 weeks.",[48,49],"Drug: Esomeprazole 20mg","Dietary Supplement: Mirgeal® Gel (manufacturer: PharmExtracta S.p.A.)",{"label":51,"type":52,"description":53,"interventionNames":54},"Esomeprazole Alone","ACTIVE_COMPARATOR","Participants will receive esomeprazole 20 mg\u002Fday alone for 4 weeks.",[48],[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":34},"DRUG","Esomeprazole 20mg","Esomeprazole 20 mg administered orally once daily for 4 weeks.",[51,44],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"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.",[44],[67],{"name":68,"role":69,"phone":70,"phoneExt":34,"email":71},"Prof. Davide Sisti, PhD","CONTACT","+39 0722 303301.","davide.sisti@uniurb.it",[73,90],{"facility":74,"status":34,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Casa di Cura Quisisana","Rome","Lazio","00197","Italy","IT",{"type":81,"coordinates":82},"Point",[83,84],12.51133,41.89193,{"lat":84,"lon":83},[87],{"name":88,"role":69,"phone":34,"phoneExt":34,"email":89},"Chiara Pasquale, MD","chiara.pasquale@virgilio.it",{"facility":91,"status":34,"city":92,"state":93,"zip":94,"country":78,"countryCode":79,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Centro per la Gastroenterologia","Mercato San Severino","Salerno","84085",{"type":81,"coordinates":96},[97,98],14.75369,40.78468,{"lat":98,"lon":97},[101],{"name":102,"role":69,"phone":34,"phoneExt":34,"email":103},"Orazio Labianca, MD","Orazio-labianca@libero.it",{"type":105,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Dr. Amjad Khan","Professor of Clinical Biochemistry and Experimental Medicine",[109],{"name":110,"class":6},"University of Urbino \"Carlo Bo\"","100653757","mirgeal-gel-as-add-on-therapy-to-esomeprazole-in-adults-with-non-erosive-gastroesophageal-reflux-disease-100653757",false,"NCT07790549","Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease","Effect of the Use of Alginate Combined With Licorice and Blueberry in the Symptomatic Treatment of Adult Patients With Gastroesophageal Reflux Disease","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Males and females.\n* Diagnosis of non-erosive gastroesophageal reflux disease (NERD), based on the absence of macroscopic lesions of the distal esophageal mucosa on endoscopy performed within 6 months prior to enrollment.\n* Heartburn and\u002For acid regurgitation at least 3 times per week during the 2 weeks prior to enrollment.\n* Written informed consent for study participation obtained prior to the start of the study.\n\nExclusion Criteria:\n\n* Active gastric or duodenal ulcer within the previous 3 months.\n* Previous surgery involving the esophagus or treated upper gastrointestinal tract.\n* Absence of erosive esophagitis or Barrett's esophagus.\n* Severe renal or hepatic impairment.\n* Use of proton pump inhibitors (PPIs), H2-antagonists, or systemic glucocorticoids within 2 weeks prior to enrollment.\n* Pregnancy.\n* Breastfeeding.\n* Alcohol or drug abuse.\n* Hypersensitivity to any of the study product components.\n* Participation in another clinical trial within 30 days prior to enrollment.\n* Lack of acceptance of written informed consent.","ALL","18 Years","75 Years",{"count":122,"type":123},140,"ESTIMATED","INTERVENTIONAL",[126],"NA","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).\n\nA total of 140 participants will be randomly assigned in a 1:1 ratio to receive either esomeprazole 20 mg\u002Fday plus Mirgeal® Gel, 2 sticks per day (1 after lunch and 1 after dinner), or esomeprazole 20 mg\u002Fday 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.",[129],"Non-Erosive Gastroesophageal Reflux Disease (NERD)","NOT_YET_RECRUITING","2026-08-25",{"date":133,"type":134},"2026-08-27","ACTUAL",{"date":136,"type":123},"2026-09-07",{"date":138,"type":123},"2027-01-29",{"name":5,"class":6},2]