CTRI/2019/10/021821
招募中
4 期
Evaluation of safety and efficacy of a proprietary digestive and carminative oral syrup formulationin the management of indigestion functional dyspepsia flatulence & anorexia in adults
East India Pharmaceutical Works Limited0 个研究点目标入组 0 人待定
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- East India Pharmaceutical Works Limited
- 状态
- 招募中
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •i. Adult subjects of both sexes between 18\-65 yrs of age.
- •ii. Presence of symptoms suggestive of indigestion, functional dyspepsia, flatulence \& anorexia, such asâ??post prandial fullness, early satiety, upper abdominal (epigastric) pain/burning/discomfort, bloating \& abdominal distension, excessive flatulence \&/or belching, nausea, vomiting, excessive regurgitation, heartburn/reflux.
- •iii. Willing to provide written informed consent.
排除标准
- •i. Pregnant or nursing women.
- •ii. Presence of heartburn as the only predominant symptom, dysphagia or jaundice.
- •iii. Suspected/known past history of peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), GI bleeding from any source, major GI/abdominal surgery (except appendicectomy).
- •iv. History, suspicion or proven presence of any other organic gastroduodenal, esophageal or hepato\-pancreatico\-biliary lesions including esophagitis, gastric atrophy, erosive gastritis, pancreatitis, cholecystitis, cholelithiasis, etc.
- •v. Chronic/recent use (within past 3 mths) of NSAIDs, corticosteroids or other drugs affecting gastric acid secretion or presence of chronic diseases requiring intermittent or chronic treatment with these drugs.
- •vi. Suffering from inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) or any other form of diarrhoea (loose stools) which could be of infectious origin.
- •vii. Suffering from any other symptoms suggestive of an ongoing infection.
- •viii. Known allergies to any constituents of the study medications.
- •ix. History of acute coronary syndrome, cerebrovascular events, end stage renal disease, or other serious diseases of vital organs like heart, kidney, liver, bone marrow, etc.
- •x. History of underlying serious psychiatric illnesses or alcohol/substance abuse.
结局指标
主要结局
未指定
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