Effectiveness and Safety of Ilaprazole versus Rabeprazole in patients of uninvestigated dyspepsia: A Randomized controlled study

Institute of Postgraduate Medical Education Research0 个研究点目标入组 122 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

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