Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Unienzyme Tablet (Fungal diastase, Papain & Activated Charcoal (100mg/60mg/75mg) Tablet: Twice daily with major meals for 4 weeks
Control Intervention1: There is no comparator Agent: No
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: All patients must meet all of the following criteria for enrollment in the study: 1. Male or female patients 18 to 60 years 2. Clinical cases of Functional Dsypepsia that fulfils Rome IV criteria with persistent symptoms of Indigestion, Abdominal fullness, Satiety on alternate days of the week for at least 4 weeks 3. Patients may have failed to adequately respond to antisecretory therapy (PPi) or H. pylori therapy involving initial or sequential therapy of PPi +Amoxicillin+ Clarithromycin/Metronidazole for cases with prior UBT
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Post prandial distress syndrome symptoms of Indigestion, Bloat (Abdominal fullness), SatietyTimepoint: At 4 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Improvement (CGI ) of efficacy ratingTimepoint: At 4 Weeks;Safety assessment for Treatment Emergent adverse eventsTimepoint: At 4 Weeks | — |
Countries
India
Contacts
Public ContactDr Rathish Nair PhD MBA
Torrent Pharmaceuticals Ltd
Outcome results
None listed