A Post approval observational study to assess safety and effectiveness of oral digestive ENZYME tablets in stomach upset.
Not Applicable
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2023/08/056549
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Post prandial distress syndrome symptoms of Indigestion, Bloat (Abdominal fullness), SatietyTimepoint: At 4 Weeks
- Secondary Outcome Measures
Name Time Method Clinical Global Improvement (CGI ) of efficacy ratingTimepoint: At 4 Weeks;Safety assessment for Treatment Emergent adverse eventsTimepoint: At 4 Weeks