An open label, multi-center, non-comparative, interventional, prospective clinical study to evaluate efficacy and safety of Ampop tablet in healthy participants. - NI

Transformative Learning Solutions Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•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

•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

发起方