Health Condition 1: null- Uninvestigated Dyspepsia
Conditions
Interventions
Intervention1: LAFUTIDINE (H2-receptor antagonist): Dose: 10mg once daily before breakfast
Route of use: Oral route
Duration of use: 8 weeks
Control Intervention1: PANTOPRAZOLE (PROTON PUMP INHIBITOR)
Sponsors
Institute of Postgraduate Medical Education Research
Eligibility
Inclusion criteria
Inclusion criteria: •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) •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 •Treatment with non-steroidal anti-inflammatory drugs (NSAIDs), H2-blockers, proton pump inhibitors, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment •Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs. •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 investigators to consider the subject unsuitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Overall Symptom Scale which is a validated 7-point Likert scale.Subjects achieving overall severity score â?¤2 in this scale were considered as responders and those achieving score of 1 were considered as having attained symptom relief.Timepoint: 8 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (mFSSGERD) and Quality of Life (QOL) as measured by short form-8 (SF-8) questionnaire.Timepoint: 8 WEEKS | — |
Countries
India
Contacts
Public ContactDr Somnath Maity
The West Bengal University Of Health Sciences
Outcome results
None listed