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

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 with functional dyspepsia

A randomized, double-blind, controlled, parallel-group phase 3 clinical trial on 50 patients

This study will be conducted on patients over 18 years of age with functional dyspepsia who visit Imam Khomeini hospital. The first group will receive the standard treatment regimen, consisting of a once-daily proton pump inhibitor, along with a placebo. The second group will receive the standard treatment together with an antacid tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate, to be taken four times a day.

Inclusion criteria: Patients over 18 years old with functional dyspepsia. Exclusion criteria: Pregnancy, breastfeeding, patients who have received a Helicobacter pylori eradication regimen containing a proton pump inhibitor within the last 28 days or who have had a positive H. pylori stool antigen test, individuals with renal, heart, or liver failure, and patients who have taken medications affecting gastric acid within the past 14 days.

In the control group, 25 adult patients with functional dyspepsia will receive a proton pump inhibitor as the standard treatment, along with a placebo. In the experimental group, 25 adult patients with functional dyspepsia will receive the standard treatment (a proton pump inhibitor) in addition to a tablet containing sodium alginate, sodium bicarbonate, and calcium carbonate.

The severity and frequency of: epigastric burning or pain, early satiety, and postprandial fullness.

In this study, volunteers were individually assigned to two groups (medication and placebo) using block randomization. Notably, 4-block randomization was used in this method. The block randomization is performed using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists, and the obtained unique codes (consisting of two English letters and one number) are assigned to each volunteer in the order of their entry into the study.

An independent individual performs the block randomization and numbers the medications and placebos based on the codes generated. The study's physician and executive only provide the patients with the medication or placebo based on each person's code and are unaware of the drug type. Likewise, the patients receive their coded medication and are unaware of their treatment type. Notably, the statistical analyst is not blinded to the groups and uses information from the aforementioned independent individual to assign patients to two groups and apply the statistical tests.

The final results of scoring the relevant parameters based on the questionnaire.

After publishing the related article in international journals.

Researchers in the field of medicine and pharmacy

Development of science and expand evidence related to treatment in further research

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