Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
None listed
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with symptomatic GERD (symptoms at least once a week for past 4 weeks) with a questionnaire-based symptom score more than 4. 2. Patients who are off proton pump inhibitor for the past 2 weeks 3. Patients who are off H2 blockers and antacids for past 1 week 4. Ready to participate
Exclusion criteria
Exclusion criteria: 1. Patients with alarm symptoms such as weight loss, gastrointestinal bleeding, dysphagia and anaemia 2. Patients who remain symptomatic on two weeks course of standard dose PPI 3. Patients with comorbidities like acute myocardial infarction, chronic kidney disease or chronic liver disease 4. Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded 5. Pregnant, lactating females 6. No history of surgery on the esophagus or stomach 7. Patients with diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with symptomatic response at 8 weeks as assessed by questionnaire (reduction in the symptom score from the pre-treatment value to a score less than equal to 4)Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with endoscopic response (improvement in endoscopic grade of esophagitis by 2 points) and remission (complete endoscopic healing) at 8 weeksTimepoint: 8 weeks;Proportion of patients with adverse events in both groupsTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Gautam Sharma
AIIMS Delhi
Outcome results
None listed