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Efficacy and Safety of Sublingual Melatonin in alleviation of reflux disease

Efficacy and Safety of Sublingual Melatonin in alleviation of GERD Symptoms

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20121021011192N12
Enrollment
280
Registered
2021-11-02
Start date
2021-11-22
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux Disease. Gastro-esophageal reflux disease without esophagitis

Interventions

Intervention 1: Intervention group: Sublingual administration of 3 miligram of melatonin daily for 4 weeks along with the omeprazole 20 mg daily. Intervention 2: Control group: Sublingual administrati

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Abbasinazari

Shahid Beheshti University of Medical Sciences

m_abbasi@sbmu.ac.ir+98 912 219 6554

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026