Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Melatonin: Oral tablet Melatonin 3mg once daily for two weeeks
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Intervention5: Omeprazole: Oral Tablet Omeprazole
Sponsors
Jamia Hamdard
Eligibility
Inclusion criteria
Inclusion criteria: Participants who will be diagnosed with gastroesophageal reflux disease, confirmed by an FSSG score of less than 32, and who will be experiencing symptoms such as heartburn or regurgitation at least two or more days per week will be included. Participants will either be prescribed omeprazole or vonoprazan and will be willing to take melatonin if required during the study. All participants who will provide written informed consent and adhere to the study protocol.
Exclusion criteria
Exclusion criteria: Participants were excluded if they had a known hypersensitivity to omeprazole, vonoprazan, or melatonin, or if they had peptic or duodenal ulcers diagnosed through endoscopy. The exclusion criteria also included the concomitant use of medications known to interact significantly with the study drugs (e.g., fluvoxamine), the use of traditional medicines for GERD, presence of a hiatus hernia, refusal to follow dietary advice, or severe symptoms indicated by an FSSG score greater than 32.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| severity scores of heartburn and epigastric painTimepoint: 2 weeks and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| patient-reported quality of life and TEAETimepoint: 2 weeks and 4 weeks | — |
Countries
India
Contacts
Public ContactIrtiqa Khan
Jamia Hamdard
Outcome results
None listed