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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230629058615N8

Enrollment

Registered

2025-05-01

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-07-21

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

Intervention 1: Intervention group: Including 25 patients who, after checking the inclusion and exclusion criteria of the study and obtaining informed consent, in addition to the standard treatment (p

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with refractory gastroesophageal reflux disease (GERD) diagnosed by a gastroenterologist Informed consent of the patient Patients over 18 years old and under 65 years old

Exclusion criteria

Exclusion criteria: Pregnancy or intention to become pregnant Patients with erosive esophagitis or esophageal cancer Patients with a history of upper gastrointestinal surgery Patients suffering from anxiety disorders or panic attacks or other mental disorders Patients who are unable to follow study instructions. Patients who have used a Helicobacter pylori eradication regimen in the last six months.

Design outcomes

Primary

Measure	Time frame
GERD score. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: The GERD score is the average of the two subscales of Regurgitation and heartburn on the Reflux Disease Questionnaire (RDQ). This questionnaire rates the severity and frequency of several symptoms associated with GERD from 0 to 5.	—

Secondary

Measure	Time frame
Side effects of sodium alginate, sodium bicarbonate, and calcium carbonate Chewable tablet. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: Ask the patient.;Regurgitation subscale score. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: The Regurgitation Score is the average of the acid taste and movement of materials symptom scores on the Reflux Disease Questionnaire, which rates the severity and frequency of several symptoms associated with GERD on a scale of 0 to 5.;Heartburn subscale score. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: The Heartburn Score is the average of the burning behind breastbone and pain behind breastbone symptom scores on the Reflux Disease Questionnaire, which rates the severity and frequency of several symptoms associated with GERD on a scale of 0 to 5.;Dyspepsia subscale score. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: The Heartburn Score is the average of the burning behind breastbone and pain behind breastbone symptom scores on the Reflux Disease Questionnaire, which rates the severity and frequency of several symptoms associated with GERD on a scale of 0 to 5.	—

Measure

Time frame

Side effects of sodium alginate, sodium bicarbonate, and calcium carbonate Chewable tablet. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: Ask the patient.;Regurgitation subscale score. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: The Regurgitation Score is the average of the acid taste and movement of materials symptom scores on the Reflux Disease Questionnaire, which rates the severity and frequency of several symptoms associated with GERD on a scale of 0 to 5.;Heartburn subscale score. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: The Heartburn Score is the average of the burning behind breastbone and pain behind breastbone symptom scores on the Reflux Disease Questionnaire, which rates the severity and frequency of several symptoms associated with GERD on a scale of 0 to 5.;Dyspepsia subscale score. Timepoint: 24 hours, 48 hours, 7 days, and 14 days after the start of the study. Method of measurement: The Heartburn Score is the average of the burning behind breastbone and pain behind breastbone symptom scores on the Reflux Disease Questionnaire, which rates the severity and frequency of several symptoms associated with GERD on a scale of 0 to 5.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSogand Habibian

Islamic Azad University

Sogand.habibian@gmail.com+98 21 2264 0051

Outcome results

None listed

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