None listed
Conditions
Interventions
Intervention1: Ampop Tablet: Subjects will be asked to take Ampop tablet in a dose of 1 tablet twice daily orally after meals with water for 1 month.
Control Intervention1: NIL: NIL
Sponsors
Transformative Learning Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2). Time to get relief from flatulence, bloating, acidity whenever it occurs during study based on subject diary. Timepoint: Day 0, Day 15, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in indigestion and appetite on graded scale 2. Changes in bowel movements 3. Changes in consistency of stool on Bristol stool scale 4. Change in quality of life assessed on WHO QOL BREF 5. Global assessment for overall change by investigator and subject 6. Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms by investigator and subject 7. Assessment of adverse events Timepoint: Day 0, Day 15, Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Transformative Learning Solutions Pvt Ltd
Outcome results
None listed