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IRCT20260727070386N1 IRCT 2026-09-03 Shahid Beheshti University of Medical Sciences Studying the effectiveness and safety of a herbal product containing ajwain and mint on healing gastric ulcers Study of the Effectiveness and Safety of a Herbal Formulation Containing Trachyspermum ammi and Mentha spp. as an Adjunct to Pantoprazole, Compared with Placebo Plus Pantoprazole, on Gastric Ulcer Healing in Patients with Gastric Ulcer 2026-09-05 anticipated 134 Recruiting https://irct.ir/trial/92042 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to either the intervention or control group using block randomization. They will receive one of the following treatment regimens: • Control group: Pantoprazole 40 mg once daily plus placebo syrup, 10 mL three times daily for one month. • Intervention group: Pantoprazole 40 mg once daily plus KDS syrup, 10 mL three times daily for one month. Three months after the initial endoscopy, a follow-up endoscopy will be performed by the same gastroenterologist to reassess ulcer healing. Ulcer stage will be evaluated using the Sakita–Miwa Classification: • Active stage (A): A1 (fresh ulcer with inflamed and edematous margins) and A2 (reduced marginal inflammation). • Healing stage (H): H1 (initial epithelialization from the ulcer margin) and H2 (reduction in ulcer size with convergence of mucosal folds). • Scar stage (S): S1 (red scar, indicating complete healing with residual redness) and S2 (white scar, indicating complete healing with normal mucosal color). Complete healing will be defined as progression to S1 or S2, or complete disappearance of the ulcer. Treatment compliance and adverse events will be assessed by telephone at 2 weeks and 1 month after initiation of treatment. Statistical analysis will be performed using SPSS version 16. Data will be analyzed using the independent t-test and chi-square test, and a p-value < 0.05 will be considered statistically significant, Blinding description: This study will be conducted as a randomized, triple-blind clinical trial. The participants, investigators, and data analyst will be blinded to treatment allocation. The herbal formulation and placebo will be identical in appearance, color, odor, volume, packaging, and labeling, and will be identified only by unique codes. The randomization codes will be securely maintained by an independent person and will not be disclosed until completion of data analysis, except in the event of a medical emergency requiring unblinding . 2-3 Gastric ulcer. Intervention 1: Intervention group: Pantoprazole 40 mg daily + KDS syrup, 10 mL three times daily, for 1 month. Intervention 2: Control group: Pantoprazole 40 mg daily + placebo syrup, 10 mL three times daily, for 1 month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the need to maintain participant confidentiality and to review ethical and data-sharing requirements, a final decision regarding the sharing of individual participant data will be made after study completion and assessment of the relevant requirements.
public Hananeh Ghalavand
No. 13, Alley 42.1, Mehram Street, Asad Abadi Square, Yousef Abad,
Tehran Iran (Islamic Republic of) 1436794614 +98 916 800 8191 Hananeh.Ghalavand@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mahdiye Abiyarghamsari
Shahid Beheshti University of Medical Sciences, No. 2660, Valiasr Street
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0118 ghamsari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with Helicobacter pylori-negative gastric ulcer Age 16-75 years 16 years 75 years Both Pregnancy Breastfeeding Use of bismuth-containing medications or antibiotics within the previous 2 weeks Gastrointestinal (GI) bleeding requiring invasive intervention Any complication of gastric ulcer Ethanol consumption or substance abuse Patients with suspected gastric cancer K25 Gastric ulcer Treatment - Drugs Placebo Intervention group: Pantoprazole 40 mg daily + KDS syrup, 10 mL three times daily, for 1 month Control group: Pantoprazole 40 mg daily + placebo syrup, 10 mL three times daily, for 1 month Percentage of patients with complete gastric ulcer healing at 3 months. Timepoint: Three months after treatment initiation. Method of measurement: Fallow-up upper gastrointestinal endoscopy. Percentage of patients with reduced gastric ulcer size after treatment. Timepoint: 3 months after treatment initiation. Method of measurement: Upper gastrointestinal endoscopy and comparison with baseline ulcer size. Percentage of patients with improved gastrointestinal symptoms after treatment. Timepoint: Two weeks and one month after treatment initiation. Method of measurement: Assessment and recording of gastrointestinal symptoms. Percentage of patients requiring additional treatment during the study. Timepoint: During the study period. Method of measurement: Recording the need for additional treatment based on the patient’s clinical status. Percentage of patients experiencing treatment-related adverse events. Timepoint: Two weeks and one month after treatment initiation. Method of measurement: Recording and assessment of patient-reported adverse events. Shahid Beheshti University of Medical Sciences Approved 2026-06-15 Ethics committee of Shahid Beheshti Medical Science University School of Pharmacy, Shahid Beheshti University of Medical Sciences, No. 2660, Valiasr Street Tehran Tehran Iran (Islamic Republic of)