A double blind, single centric, randomized, placebo-controlled study to demonstrate the efficacy and safety of RefluG (Test product) with Placebo in the management of symptoms of Gastroesophageal reflux disease (GERD).

Giellepi Spa0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 已完成
发起方: Giellepi Spa
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1 Patient should be able to give written informed consent.
•2 Diagnosis of GERD by endoscopy
•3 Males and females 18 -65 years of age (both inclusive).â?¨
•4 Subjects who should be able to follow controlled diet (coffee and tea must be limited to not more than 2 cups per day, Chocolate, alcoholic beverages and spices should be reduced as much as possible).
•5Subjects who are negative for Helicobacter pylori infection
•6 Childbearing women using either oral or local contraceptives.
•7 Ability to comply with requirements of trial

排除标准

•Subjects with esophagitis and complications of gastroesophageal reflux disease including oesophageal stricture, Barrettâ??s oesophagus or adenocarcinoma of the oesophagus
•Subjects with any significant intestinal maladies (including known gastric and duodenal ulcer, hiatal hernia, infections or inflammatory conditions of the small or large intestine, and obstructions)
•Subjects with dyspepsia, Malabsorption, celiac disease, prior gastric surgery, pyloric stenosis, or a history of erosive esophagitis or GERD refractory to 2 months of therapy with either an H2-receptor antagonist (H2RA) or a PPI.
•Known history of drug or alcohol abuse
•Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
•Subjects with clinically significant history of co-morbid condition (like, diabetes, immunodeficiency, HIV, HPV), cardiac disease, kidney disease, that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
•Patients suffering from any condition which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. sub-acute obstruction, celiac disease, Crohnâ??s disease, Small intestine bacterial overgrowth (SIBO), chronic pancreatitis, or cystic fibrosis, lactase deficiency, or lactose intolerance, biliary atresia, parasitic diseases, diseases of the gallbladder, liver, kidney or pancreas etc.
•Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease (e.g, chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome)
•9.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values >= 2.5 X Upper Limit of Normal (ULN), Serum creatinine of >= 1.5 mg/dL
•10.Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
•Subjects participating in any other studies or participated in any clinical trial 3 months prior to start of this trial.
•Pregnant women.
•Known hypersensitivity to, or intolerance of, study medications or their formulation excipients.

研究者

发起方

Giellepi Spa

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