Health Condition 1: null- Uninvestigated Dyspepsia
Conditions
Interventions
Intervention1: Ilaprazole: a proton pump inhibitor
Dose: 10mg
Route: Oral
Frequency: daily, early morning in empty stomach for a duration of 6 weeks.
Control Intervention1: Rabeprazole: a proton pump
Sponsors
Institute of Postgraduate Medical Education Research
Eligibility
Inclusion criteria
Inclusion criteria: • Patients, of either sex, aged between 18 - 55 years. • Symptoms of dyspepsia for at least 1 months • Moderate-to severe symptoms (score >= 4 on the7-point Likert scale for each symptom in global overall symptoms scale).
Exclusion criteria
Exclusion criteria: • Patient with alarm features (unintentional weight loss, persistent vomiting, dysphagia, hemetemesis, melena, fever, jaundice, or anemia), • History of serious gastrointestinal disease (including peptic ulcers, malignancy, esophageal dysmotility, a previous endoscopic or radiological diagnosis of GERD and Barrettâ??s esophagus) • History of irritable bowel syndrome. • Recent gastrointestinal surgery i.e. within 30 days • Patients with angina pectoris. • Patients who show any of the following values at the baseline laboratory tests: Hemoglobin = 100 IU/L, Creatinine >= 1.5 mg/dL The blood tests should have been done not more than 4 weeks prior to enrollment. • Treatment with non-steroidal anti-inflammatory drugs (NSAIDs), H2-blockers, proton pump inhibitors, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment • Concomitant use of psychotropic drugs. • Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs. • History of hypersensitivity to either of the study drugs or closely allied drugs. • Women who are pregnant, lactating, or not willing to use adequate methods of contraception. • History of substance abuse. • Any other condition which can lead the study investigators to consider the subject unsuitable for selection. • Patient participating in any other clinical trial or have participated in the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Overall Symptom Scale (7 point Likert scale)Timepoint: 0 months,3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Modified Frequency Scale for the Symptom of gastroesophageal reflux disease (mFSSGERD) 2. Quality of life (QOL) as measured by SF8 QOL questionnaire Timepoint: 1.Modified Frequency Scale for the Symptom of gastroesophageal reflux disease (mFSSGERD)at 0 months,3 months, 6 months 2. Quality of life (QOL) as measured by SF8 QOL questionnaire at 0 months,6 months | — |
Countries
India
Contacts
Public ContactSourav Das Choudhury
Institute of Postgraduate Medical Education & Research
Outcome results
None listed