Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients having GERD symptoms like heart burn, regurgitation, epigastric pain,bloating, dysphagia, nausea for more than 3 weeks 2. Patients willing to participate and given written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant / Lactating mother 2. Patient with malignancy, history of abdominal surgeries, any major hematologic, hepatic, metabolic gastrointestinal or endocrine disorders requiring any other anti GERD medications 3. Patients with impaired liver and renal function 4. Patients with abnormal laboratory tests at baseline (including liver enzymes greater than twice the upper limit of normal), 5. Patients refractory to a 2-month course of H2-blocker or PPI therapy for GERD treatment, 6. Patients who took PPI within 14 d of screening or a H2-blocker or prokinetic agent within 7 d of screening, 7. Oral steroids, aspirin or who were unable to discontinue the use of anticholinergics, cholinergics, spasmolytics, opiates or sucralfate 8. Patients with poorly controlled associated disease (such as heart disease, coagulation disorders, thyroid disorders) were also excluded from the study 9. Patients who required daily use of non-steroidal anti-inflammatory drugs (NSAIDs),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the improvement in GERD symptomsTimepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| GI endoscopy changesTimepoint: 28days | — |
Countries
India
Contacts
Karpaga vinayaga institute of medical sciences and research centre