Assessment of the effectiveness of a Mastic traditional formulation in the treatment of gastrointestinal reflux, compared with Omeprazole; a clinical study
Phase 3
- Conditions
- gastric reflux.
- Registration Number
- IRCT20191212045709N2
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
Heartburn
early satiety
Nausea/vomiting
Bloating
Upper abdominal pain
Lower abdominal pain
Exclusion Criteria
Liver disease
kidney disease
Heart disease
Mental retardation
Children with underlying disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heartburn-early satiety-Nausea/vomiting-Bloating- Upper and lower abdominal pain-. Timepoint: At the beginning of the study and after 4 weeks. Method of measurement: Through a doctor's visit.
- Secondary Outcome Measures
Name Time Method The intervention group consumes 2 capsules containing mastic (2 units), cardamom (2 units), cumin (2 units) and ginger (2 units) daily along with omeprazole. The control group used omeprazole in addition to the starch-containing capsules. Nausea, early satiety, bloating, and pain in the upper and lower abdomen are assessed by a physician at the beginning and end of the study. Timepoint: At the beginning of the study and after 4 weeks. Method of measurement: Through a doctor's visit.