Health Condition 1: K296- Other gastritis
Conditions
Interventions
None listed
Sponsors
Arunveda
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age between eighteen and fifty five years, male or non pregnant female. 2.Presenting with mild to moderate hyperacidity symptoms such as bloating or distension, acid reflux or heartburn sensation, early satiety during meals, upper abdominal pain or discomfort, burning in the upper abdomen or central chest, nausea, vomiting, burping or flatulence. 3.History of the above symptoms for greater than or equal to six months before screening. 4.Willing and able to provide written informed consent. 5.Agrees to comply with study requirements, scheduled visits and dietary guidance during participation.
Exclusion criteria
Exclusion criteria: 1.Known diagnosis of tuberculosis, hepatitis B or hepatitis C, HIV infection, ischemic heart disease, cancer, chronic kidney disease or chronic liver disease. 2.Presence of active jaundice or other signs of acute hepatitis. 3.History of functional dyspepsia, functional gastrointestinal disorder or irritable bowel syndrome that may affect symptom assessment. 4.Participation in another clinical trial or use of any investigational product within thirty days before screening. 5.Use of antacids, H2 receptor antagonists, proton pump inhibitors or sucralfate within seven days before baseline, unless discontinued during a washout period. 6.Pregnant or lactating women. 7.Any clinically significant abnormal laboratory or physical examination finding that, in the investigator s judgment, may interfere with study participation or data interpretation. 8.Known hypersensitivity to any herbal or excipient component of Gasoleen Digestive Pills. 9.Any other condition which, in the opinion of the investigator, makes the participant unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Mean change in gastric pH between Baseline (Day 0) and End of Study (Day 7 1). - Mean change in fecal pH between Baseline (Day 0) and End of Study (Day 7 1). Timepoint: Baseline (Day 0) End of Study (Day 7 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint: ;- Change in composite symptom-severity scores (bloating, reflux, early satiety, pain, burning, nausea, vomiting, burping, and flatulence) from Baseline to End of Study will be assessed. - Change in WHOQOL-BREF domain scores (physical, psychological, social, and environmental) will be assessed. - The proportion of participants rated Improved or Much Improved by the investigator and participant will be assessed. - The incidence, type, severity, causality, and outcome of AEs/SAEs, along with changes in vital signs and physical examination findings, will be assessed. - The percentage of doses taken versus dispensed and qualitative feedback on acceptability will be assessed.Timepoint: Baseline (Day 0) End of Study (Day 7 1). | — |
Countries
India
Contacts
Public ContactMamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed