The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
- Registration Number
- NCT00915616
- Lead Sponsor
- Mansoura University
- Brief Summary
Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Many drugs used for the treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. The aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- patient with GERD ranged from 42 to 56 years
Exclusion Criteria
- patients with cardiac disease
- patients with renal affection
- patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis)
- patients on the drugs known to affect the GIT motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group II Melatonin Included 9 patients suffering from GERD; receiving melatonin alone for treatment of GERD in a dose of 3 mg once daily at the bed time. Group IV Melatonin Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method