Health Condition 1: null- Acid Peptic Disorder
Conditions
Interventions
Intervention1: Troxipide: 100 mg tablet to be administered thrice daily per orally for 28 days
Control Intervention1: Rabeprazole: 20 mg tablet to be administered once daily per orally for 28 days
Sponsors
Government Medical College Hospital
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with symptoms of dyspepsia having Glasgow Dyspepsia Severity Score > 2 OR • Patients undergoing upper gastro intestinal endoscopy having signs of any of acid peptic disorder AND • Subjects who provide a written informed consent
Exclusion criteria
Exclusion criteria: • History of any diagnosed gastrointestinal disorder other than acid peptic disorder • History of any previous abdominal / gastrointestinal surgery • History of treatment with drugs capable of interfering with digestive mucosal integrity, acid secretion or gastrointestinal motility, (including H2 receptor antagonists, NSAIDs, muscarinic antagonists, cytoprotective agents) within the previous 7 daysys • Requires concomitant medication which precludes the evaluation of study medications • Patients with signs suggestive of any acute complication of acid peptic disorder • Any contraindication for endoscopy examination • Evidence of gastric malignancy, pyloric obstruction, or oesophageal stricture on endoscopy • Patients who are drug or alcohol abusers • Patients with known hypersensitivity to any of the ingredients of the test / Comparator formulation • Patients with impairment of renal or hepatic function, severe cardiac disease, any respiratory disease or haematological abnormality • Pregnant or lactating females • Simultaneous participation in another clinical study 30 days prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of patients with improvement of symptoms severity score â?¢ Proportion of patients with improvement on endoscopic evaluationTimepoint: â?¢ Symptom score: Day 0, Day 14, Day 28 â?¢ Endoscopic Evaluation: Day 0, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Adverse event frequency and severityTimepoint: As and when it occurs;â?¢ Global assessment of efficacy and tolerance by investigator at end of treatmentTimepoint: Day 0, Day 28;â?¢ Incidence of Rescue medication useTimepoint: Day 28;â?¢ Laboratory Investigations for safety assessmentTimepoint: Day 0, Day 28;â?¢ Symptom severity Sub scoresTimepoint: Day 0, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Government Medical College, Aurangabad
Outcome results
None listed