The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
|ClinicalTrials.gov Identifier: NCT00915616|
Recruitment Status : Withdrawn
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
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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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Drug: Melatonin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease|
No Intervention: control
9 healthy normal subjects.
Active Comparator: Group II
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.
No Intervention: Group III, combined group
Included 9 patients suffering from GERD; receiving omeprazole alone for treatment of GERD in a dose of 20 mg twice daily.
Active Comparator: Group IV
Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.
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