CTRI/2018/05/013993尚未招募不适用
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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in Gastro Intestinal Symptom Rating Scale, Glasgow Dyspepsia Severity Score ,Nepean Dyspepsia Index from baseline to end of the study
研究概览
简要总结
Thisis a randomized, double blind, placebo controlled, parallel group, multicenterstudy. The main purpose of the study is to prove the efficacy of Asdamarin as ahealth supplement in subjects suffering from dyspepsia. Subjects diagnosed withdyspepsia meeting all inclusion and no exclusion criteria will sign a writteninformed consent and will be enrolled in the study.Safety and and efficacy will be established by comparing the study parameter values from baseline to end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Changes in Gastro Intestinal Symptom Rating Scale, Glasgow Dyspepsia Severity Score ,Nepean Dyspepsia Index from baseline to end of the study
时间窗: Day 0, Day 07
次要结局
- Change in Hematological and Biochemical Safety Parameters(Day 0, Day 07)
- Incidence of Adverse Events(Day 07)
研究者
研究点 (1)
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