Efficacy of banhasasim-tang on functional dyspepsia: a randomised, double blind, placebo controlled, two-centre trial

Korea Health Industry Development Institute (KHIDI) (South Korea)0 个研究点目标入组 100 人开始时间: 2009年9月18日最近更新: 2019年3月25日

适应症

试验速览

•1. Typical functional dyspepsia according to ROME III criteria
•1.1. One or more of:
•1.1.1. Bothersome post-prandial fullness
•1.1.2. Early satiation
•1.1.3. Epigastric pain
•1.1.4. Epigastric burning
•1.2. No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
•2. The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms
•3. Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks
•4. Regardless of sex, age range between 18 and 75 year old
•5. Written and informed consent

•1. History of peptic ulcer or gastroesophageal reflux disese (GERD)
•2. Current prominent symptoms of irritable bowel syndrome or GERD
•3. Presence of the following alarm symptoms:
•3.1. Severe weight loss
•3.2. Black or tar stool
•3.3. Dysphagia
•4. Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders
•5. Women in pregnancy and lactation
•6. History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system
•7. Participation of other clinical trials within the last 3 months
•8. Severe mental problems or drug abuse
•9. Judged by expert that they are appropriate to participate in this study

发起方

Korea Health Industry Development Institute (KHIDI) (South Korea)