CTRI/2018/05/013993尚未招募未知
A randomized, double blind, placebo controlled, parallel group study to evaluate the Safety and Efficacy of Asdamarin in subjects with non- ulcer functional Dyspepsia.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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.Fulfilling Rome III diagnostic criteria for functional dyspepsia
- •2.Must be willing and able to give informed consent and comply with the study procedures
- •3.Female subjects who are non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator
排除标准
- •1History of peptic ulcer, gastro oesophageal reflux disease, gastro intestinal surgery or any other clinically significant gastro intestinal disease, gastrointestinal bleeding, mechanical obstruction, perforation, gastrointestinal cancer.
- •2Subjects who have taken antibiotics or any other drugs in last 2 weeks with primary site of action in the gastro intestinal tract
- •3History of psychiatric illness
- •4History of congestive heart failure or uncontrolled hypertension
- •5Subjects with abnormal haematological or biochemical parameters
- •6Pregnant or lactating women or those planning for conception
- •7Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
研究者
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