Efficacy and Safety of Sublingual Melatonin in alleviation of reflux disease

Phase 3

Recruiting

• Conditions: Gastroesophageal reflux Disease.; Gastro-esophageal reflux disease without esophagitis; K21.9

• Registration Number: IRCT20121021011192N12
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Patients above 18 years old with compliant of heartburn, pain in behind of sternum in two or more days of week and FFSG score above or equal 8
Obtaining consent form for entry the study

Exclusion Criteria

Patients with diagnosis of gastric or duodenal ulcer
Pregnant or breastfeeding women
Person who consume recently antacid medications
Person who under treatment of relaxing agents of gastroesophageal sphincter
Liver diseases (Child C)
Kidney injury (AKIN classification stage 3)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of Frequency Scale for the Symptoms of GERD (FSSG score). Timepoint: Before intervention and 4 weeks after initiation of daily use of melatonin. Method of measurement: Frequency Scale for the Symptoms of GERD questionairre (FSSG questionairre).