Assessing the effectiveness of adding an antacid tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate to proton pump inhibitors in patients with functional dyspepsia

Assessing the effectiveness of adding an antacid tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate to a proton pump inhibitor for improving epigastric pain or burning, early satiety, and postprandial fullness in patients over 18 with functional dyspepsia versus placebo: A randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230629058615N10

Enrollment

Registered

2025-09-09

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Functional dyspepsia. Functional dyspepsia

Interventions

Intervention 1: The intervention group: It consists of 25 patients who, after meeting the study's inclusion and exclusion criteria and providing informed consent, will receive an antacid tablet contai

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with functional dyspepsia based on the Rome IV criteria Patients over 18 years old Patients who have filled out an informed consent form and are aware of the study process

Exclusion criteria

Exclusion criteria: Pregnant and lactating women Patients with renal failure (GFR8% and fasting blood glucose> 180 mg/dl ) or uncontrolled blood pressure (blood pressure > 160/100 mmHg) Patients with dyspepsia whose symptoms are relieved by defecation or are associated with a change in the frequency or consistency of their stool

Design outcomes

Primary

Measure	Time frame
The severity and frequency of epigastric pain. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of epigastric burning. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of early satiety. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of postprandial fullness. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of epigastric pain. Timepoint: Before starting the study and 3 days after the start of the study. Method of measurement: The Visual Analogue Scale with a score from one to ten.;The severity and frequency of epigastric burning. Timepoint: Before starting the study and 3 days after the start of the study. Method of measurement: The Visual Analogue Scale with a score from one to ten.	—

Measure

Time frame

The severity and frequency of epigastric pain. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of epigastric burning. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of early satiety. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of postprandial fullness. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.;The severity and frequency of epigastric pain. Timepoint: Before starting the study and 3 days after the start of the study. Method of measurement: The Visual Analogue Scale with a score from one to ten.;The severity and frequency of epigastric burning. Timepoint: Before starting the study and 3 days after the start of the study. Method of measurement: The Visual Analogue Scale with a score from one to ten.

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Secondary

Measure	Time frame
Side effects of antacid tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate. Timepoint: 14 days after the start of the study. Method of measurement: Questioning the patient.;Improving the quality of life of patients receiving antacid tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate in addition to a standard treatment. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.	—

Measure

Time frame

Side effects of antacid tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate. Timepoint: 14 days after the start of the study. Method of measurement: Questioning the patient.;Improving the quality of life of patients receiving antacid tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate in addition to a standard treatment. Timepoint: Before starting the study and 14 days after the start of the study. Method of measurement: The Short Form Nepean Dyspepsia Index Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSetare Abolghasemi

Islamic Azad University

sohaabolghasemi@gmail.com+98 21 2264 0051

Outcome results

None listed

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