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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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control

9 healthy normal subjects.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group IV

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

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

Interventions

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Melatonin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

42 Years

Maximum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes