A clinical trial to study the effects of two drugs, Ilaprazole and Rabeprazole in patients with uninvestigated dyspepsia
- Conditions
- Health Condition 1: null- Uninvestigated Dyspepsia
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 122
•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).
•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 < 9.5 g/dL, total leukocyte count < 3,000/mm3, platelet count < 75,000/mm3, AST and ALT >= 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Global Overall Symptom Scale (7 point Likert scale)Timepoint: 0 months,3 months, 6 months
- Secondary Outcome Measures
Name Time Method 1.Modified Frequency Scale for the Symptom of gastroesophageal reflux disease (mFSSGERD) <br/ ><br>2. Quality of life (QOL) as measured by SF8 QOL questionnaire <br/ ><br>Timepoint: 1.Modified Frequency Scale for the Symptom of gastroesophageal reflux disease (mFSSGERD)at 0 months,3 months, 6 months <br/ ><br>2. Quality of life (QOL) as measured by SF8 QOL questionnaire at 0 months,6 months