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IRCT20230629058615N10 IRCT 2025-09-09 Islamic Azad University 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 2025-10-23 anticipated 50 Complete https://irct.ir/trial/81937 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Functional dyspepsia. 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 containing sodium alginate, sodium bicarbonate, and calcium carbonate, produced by Tamin Salam Arapharmed pharmaceutical company. The tablets will be administered four times a day. This is in addition to their standard treatment (a proton pump inhibitor once daily). The treatment duration is 14 days. Patients will be evaluated at three time points: before the study begins, and at 3 and 14 days after the start of treatment. Intervention 2: The control group: It consists of 25 patients who, after meeting the study's inclusion and exclusion criteria and providing informed consent, will receive standard treatment (a proton pump inhibitor once daily) and a placebo, produced by Tamin Salam Arapharmed pharmaceutical company, four times daily. The treatment duration is 14 days. Patients will be evaluated at three time points: before the study begins, and at 3 and 14 days after the start of treatment. Yes - There is a plan to make this available What will be shared: The final results of scoring the relevant parameters based on the questionnaire. When: After publishing the related article in international journals. To whom: Researchers in the field of medicine and pharmacy Conditions: Development of science and expand evidence related to treatment in further research Where to obtain: Islamic Azad University, Tehran Medical Sciences Branch: Respected applicants can use the following method to receive their desired documents or data from Islamic Azad University, Tehran Medical Sciences Branch: Communication with the Research and Technology Unit: To receive information and documents related to research and clinical trials, applicants can refer to the Research and Technology Unit of the university. Postal Address: Administrative Building Address: Administrative Building of Tehran Islamic Azad University of Medical Sciences, Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak, Dr. Shariati Street, Tehran, Iran. Contact Number: 26602642-3 Email: rezazadeh.am@iums.ac.ir Website: www.tms.iau.ir How to obtain: Request Submission and Documentation/Data Retrieval Process from the Research and Technology Department: Request Submission: Applicants must submit their request in writing, including full details (type of documents or data, purpose of request, and related supplementary information) to the university's Research and Technology Department. Method of Submission: Requests can be delivered in person to the Research and Technology Department. Postal Address: Administrative Building Address: Administrative Building of Tehran Islamic Azad University of Medical Sciences, Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak, Dr. Shariati Street, Tehran, Iran. Phone Number: 26602642-3. Request Review: After receiving the request, the Research and Technology Department staff will review it. This review includes assessing the content of the request and determining if additional information is needed. If further clarification or adjustments are required, the applicant will be contacted via email or phone. Document/Data Delivery: Once prepared, the requested documents or data will be delivered to the applicant either in person or electronically. Delivery Methods: Electronic: Sent via email. Final Delivery Timeframe: 1 to 2 business days after preparation.Follow-up and Communication: Applicants can contact the Research and Technology Department at any stage of the process to follow up on the status of their request. Phone Number: 26602642-3. Estimated Overall Timeframe for Receiving Documents/Data: From the time the request is submitted until the final receipt of documents or data, the process typically takes between 15 and 20 business days. Comments:
public Setare Abolghasemi
No. 99, Yasaman St., Yakhchal St, Shariati Ave.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 sohaabolghasemi@gmail.com Islamic Azad University scientific Amir Rezazadeh
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (shahin Shomali) St, Hemmat Highway
Tehran Iran (Islamic Republic of) 1475886671 +98 912 729 8761 rezazadeh.am@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both Pregnant and lactating women Patients with renal failure (GFR<30), liver failure (Child Pugh B, C), or heart failure (NYHA class 3, 4) Patients who received a Helicobacter pylori eradication regimen containing a proton pump inhibitor within the last 28 days, and individuals with a positive H. pylori stool antigen test within the last 28 days Individuals who have taken any of the following medications within the past 14 days: Sucralfate, Misoprostol, Proton pump inhibitors, H2-receptor antagonists, Antacids, Prokinetics, Anticholinergics, Glucocorticoids, or Non-steroidal anti-inflammatory drugs (This excludes aspirin at a dose of less than 325 mg for cardiovascular disease prevention) Individuals with a history of the following: gastrointestinal surgery, significant cardiopulmonary, metabolic, hematologic, hepatic, renal, neurologic, and psychiatric disorders, malignancy, gastrointestinal ulcers and obstructions, history of peptic ulcer, reflux esophagitis, and Barrett's or erosive esophagitis within the past 6 months People with uncontrolled diabetes (HbA1c >8% 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 K30 Functional dyspepsia Treatment - Drugs Placebo 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 containing sodium alginate, sodium bicarbonate, and calcium carbonate, produced by Tamin Salam Arapharmed pharmaceutical company. The tablets will be administered four times a day. This is in addition to their standard treatment (a proton pump inhibitor once daily). The treatment duration is 14 days. Patients will be evaluated at three time points: before the study begins, and at 3 and 14 days after the start of treatment. The control group: It consists of 25 patients who, after meeting the study's inclusion and exclusion criteria and providing informed consent, will receive standard treatment (a proton pump inhibitor once daily) and a placebo, produced by Tamin Salam Arapharmed pharmaceutical company, four times daily. The treatment duration is 14 days. Patients will be evaluated at three time points: before the study begins, and at 3 and 14 days after the start of treatment. 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. 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. Tamin Salam Arapharmed Pharmaceutical Company Approved 2025-08-19 The Research Ethics Committees of Pharmacy and Pharmaceutical Sciences- Islamic Azad University No. 99, Yasaman St., Yakhchal St, Shariati Ave. Tehran Tehran Iran (Islamic Republic of)