Evaluation of efficacy and safety of Spasmodigestin® enteric coated tablets in patients with functional dyspepsia: a prospective, open label, interventional phase IV study

TCD MENA0 个研究点目标入组 251 人开始时间: 2022年9月5日最近更新: 2022年9月19日

适应症

试验速览

暂无简介。

•1. Aged =18 years and <60 years
•2. Patients with functional dyspepsia who are defined as having upper abdominal pain or discomfort with one or more of the following symptoms: early satiety, postprandial fullness, bloating and nausea with the absence of GIT clinically significant findings.
•3. Patients with acute onset of dyspeptic symptoms for less than 6 months and able to provide written informed consent.

•1. Patients with chronic onset of dyspeptic symptoms for more than 6 months
•2. Patients with inflammatory bowel disease (IBS), chronic calcular cholecystitis, lactose intolerance, psychiatric disorder requiring medication, major hepatic, renal or haematological diseases.
•3. Patients with history of malignancy, laparoscopic or open abdominal surgery within the previous 6 months
•4. Patients with history of the following diseases within the previous 6 months; peptic ulcer disease, GI bleeding, gastroesophageal reflux disease, intestinal stenosis or obstruction, infectious diarrhoea, or pancreatitis Also, patients with Unexplained iron deficiency anaemia, unintentional weight loss, dysphagia or persistent vomiting at time of study.
•5. Patients with known allergy to the study drug. or taking concomitant medication acting on or influencing the gastrointestinal system (e.g., proton-pump inhibitors, H2 blockers, cholagogues, prokinetic agents, non-steroidal inti-inflammatory drugs, or theophylline).
•6. Patients on antidepressant or anxiolytic treatment.
•7. Pregnant or lactating female patients.
•8. Female patients of childbearing age not using contraception.

发起方

TCD MENA