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临床试验/NCT00915616
NCT00915616撤回3 期

The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

Mansoura University0 个研究点开始时间: 2009年6月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回

研究概览

简要总结

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.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
42 Years 至 56 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patient with GERD ranged from 42 to 56 years

排除标准

  • 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

研究组 & 干预措施

Group II

Active Comparator

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.

干预措施: Melatonin (Drug)

Group IV

Active Comparator

Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.

干预措施: Melatonin (Drug)

研究者

申办方类型
Other

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