An open label, multi-center, non-comparative, interventional, prospective clinical study to evaluate efficacy and safety of Ampop tablet in healthy participants.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- 1). Changes in duration, number of episodes and severity of symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, and flatulence
研究概览
简要总结
Itis an open label, multi-center, non-comparative, interventional, prospectiveclinical study to evaluate efficacy and safety of Ampop tablet in healthyparticipants. The study will be carried outat two centers in India. Subjects will be asked to take Ampop tablet in adose of 1 tablet twice daily orally after meals with water for 1 month. Primaryobjective of the study will be to assess changes in duration, number of episodes and severityof symptoms including bloating, feeling of acid reflux, early fullness during ameal, pain or discomfort in the upper abdomen, burning in the upper abdomen,pain/burning in the center of chest, nausea, vomiting, burping, and flatulenceand time to get relief from flatulence, bloating, acidity whenever it occursduring study based on subject diary. Secondary objectives of the study will be to assess changes in indigestion and appetite on graded scale, changes in bowel movements,changes in consistency of stool on Bristol stool scale, change in quality oflife assessed on WHO QOL BREF, global assessment for overall change byinvestigator and subject, global assessment of tolerability of study product byassessing ADRs, vitals and clinical symptoms by investigator and subject andadverse events on day 0,day 15, day 30
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy males and females with any of the mild to moderate symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain, or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, flatulence, indigestion, and appetite.
- •(Healthy individuals will be defined as those who are not taking any medications and do not require continuous medical care and monitoring) 2.Subjects must be suffering from any of the above symptoms at least from last six months.
- •3.Ready to provide written consent and follow all the study procedure.
排除标准
- •1.Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart disease, cancer, kidney failure, chronic liver diseases, 2.Subjects having jaundice or any other symptom of active hepatitis 3.Subjects with any other investigational product within 1 month prior to randomization 4.Subject suffering from any other functional dyspepsia, or any other functional gastrointestinal disorder 5.Subjects with diabetes mellitus and hypertension taking regular medications 6.Pregnant and lactating women 7.Subjects with any significant abnormal laboratory parameters 8.Known hypersensitivity to any of the ingredients of Ampop Tablet 9.Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
结局指标
主要结局
1). Changes in duration, number of episodes and severity of symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, and flatulence
时间窗: Day 0, Day 15, Day 30
2). Time to get relief from flatulence, bloating, acidity whenever it occurs during study based on subject diary.
时间窗: Day 0, Day 15, Day 30
次要结局
- 1.Changes in indigestion and appetite on graded scale(2.Changes in bowel movements)