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IRCT20141201020178N6 IRCT 2018-02-04 Iran University of Medical Sciences The effect of ِِِِDuloxetine with lansoprazole on the treatment of Gastroesophageal reflux disease A Comparison between lansoprazole with placebo and lansoprazole with duloxetine regimens on symptom and quality of life improvement in patients with Gastroesophageal reflux diseases 2017-12-03 anticipated 54 Complete https://irct.ir/trial/28074 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computerized random Table, Blinding description: After explanation for patients about the study, and getting written concent form ,all the enrolled patients are blindly randomized to each group. Outcome assessors dont informed about the type of regimens in this study. 3 gastroesophageal reflux. Intervention 1: Intervention group: Tablet Lansoprazole 30 mg daily with Capsule Duloxetine 30 mg daily(Abidi company). Intervention 2: Control group: Tablet Lansoprazole 30 mg daily with Capsule placebo daily(Abidi company). Yes - There is a plan to make this available What will be shared: IPD collected for primary outcome could be shared When: starting in September 2018 To whom: People working in academic institutions Conditions: Just analyzed data Where to obtain: Email address Research Administrator of Colorectal Research Center, Marjan Mokhtare How to obtain: After applying for analyzed data by email, we review it and answer them Comments:
public Marjan Mokhtare
Colorectal Research Center, Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4790 marjanmokhtare@yahoo.com Iran University of Medical Sciences scientific Marjan Mokhtare
Colorectal Research Center,Rasoul Akram Hospital,Niayesh Street,Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4790 marjanmokhtare@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) age between 18-65 Typical symptoms of Gastro -esophageal reflux disease (heartburn, regurgitation)and/ or endoscopic findings of Gastroesophageal reflux disease 18 years 65 years Both Use of recent or previous anti-depressants and anti- anxiety drugs A history of allergy to any of the medications History of alcohol consumption Atypical symptoms of Gastro esophageal reflux disease Previous history of anxiety or depression History of opium use History of upper gastrointestinal disorders(Dyspepsia and/or Peptic ulcer disease) History of cardiac , pulmonary , musculoskeletal disease and any malignancy. History of medications such as: Sildenafil, calcium channel blocker, methylxanthine, nitrate and beta-agonist Age under 18 years Age older than sixty-five K21 Gastro-esophageal reflux disease Treatment - Drugs Treatment - Drugs Intervention group: Tablet Lansoprazole 30 mg daily with Capsule Duloxetine 30 mg daily(Abidi company) Control group: Tablet Lansoprazole 30 mg daily with Capsule placebo daily(Abidi company) Quality and symptoms of patients with gastroesophageal reflux Disease. Timepoint: Before starting the intervention and 4 weeks later. Method of measurement: Patient Assessment of gastroesophageal re flux Quality of life and symptom Questionnaires. Adverse effect of medications. Timepoint: 2 and 4 weeks after starting the intervention. Method of measurement: Data gathering sheet of patients. Iran University of Medical Sciences Approved 2017-12-03 Ethics Committee of Iran University of Medical Sciences West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori Tehran Tehran Iran (Islamic Republic of)