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Effectiveness of adding sodium alginate, sodium bicarbonate, and calcium carbonate suspension to proton pump inhibitor in refractory gastroesophageal reflux

Efficacy of adding sodium alginate, sodium bicarbonate, and calcium carbonate suspension to proton-pump inhibitor in patients with refractory gastroesophageal reflux disease: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230629058615N7
Enrollment
50
Registered
2025-01-19
Start date
2025-02-13
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Refractory gastro-esophageal reflux disease. Gastro-esophageal reflux disease without esophagitis

Interventions

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Patients with refractory GERD diagnosed by a gastroenterologist 2) Informed consent of the patient 3) Patients over 18 years old and under 65 years old

Exclusion criteria

Exclusion criteria: 1) Pregnancy or intention to become pregnant 2) Patients with erosive esophagitis or esophageal cancer 3) Patients with a history of upper gastrointestinal surgery 4) Patients suffering from anxiety disorders or panic attacks or other mental disorders 5) Patients who use prokinetics, histamine 2 receptor antagonists (H2RAs), proton pump inhibitors (PPIs), cholinergic, or anticholinergic agents within one month after registration. 6) Patients who have used a Helicobacter pylori eradication regimen within six months before registration.

Design outcomes

Primary

MeasureTime frame
The severity and frequency of: 1) acid taste 2) movement of material 3) burning behind the breastbone 4) pain behind the breastbone 5) upper stomach pain 6) upper stomach burning. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: RDQ questionnaire, scoring from zero to five.

Secondary

MeasureTime frame
Side effects of sodium alginate, sodium bicarbonate, and calcium carbonate suspension. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: Ask the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Ahmadi

Islamic Azad University

mhmdrzah79@gmail.com+98 21 2264 0051

Outcome results

None listed

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