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IRCT20230408057842N1 IRCT 2023-04-18 Shahid Beheshti University of Medical Sciences The effect of celecoxib in the treatment of gastric metaplasia Effect of celecoxib on alleviation of gastric intestinal metaplasia in patients with positive helicobacter pylori 2023-05-05 anticipated 80 Complete https://irct.ir/trial/69504 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to two arms, using block randomization method. The block size is four, involving patients would be based on order’s coming) which would generated by online block randomization software “Sealed Envelope”. The list of random blocks will be placed in envelopes, daily would be opened by the staffs, Blinding description: In this design, the data analyst is subject to blinding, so he/she does not know that each data is related to which patient. 4 gastric intestinal metaplasia. Intervention 1: Intervention group: In this group, patients will simultaneously receive the four-drug regimen of Helicobacter pylori, including omeprazole 20 mg, amoxicillin 500 mg, metronidazole 500 mg, and clarithromycin 500 mg along with celecoxib 100 mg (Hakim Company). Intervention 2: Control group: In the control group, only the four-drug regimen of Helicobacter pylori including omeprazole 20 mg, amoxicillin 500 mg, metronidazole 500 mg, and clarithromycin 500 mg is prescribed for patients. 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 Regarding the presentation of data analysis results, raw data will not be provided to others
public Amir Fallahnia
Arabi street, velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 drafallahnia@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mohammad Javad Ehsani Ardakani
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 mjehsani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old All patients were diagnosed with gastric metaplasia 18 years no limit Both Patients with malignancy Patients who had been treated with regular nonsteroidal anti-inflammatory drugs (NSAIDs), proton-pump inhibitors, bismuth salts, or antibiotics within two weeks before endoscopy heart failure renal dysfunction pregnancy liver cirrhosis Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients will simultaneously receive the four-drug regimen of Helicobacter pylori, including omeprazole 20 mg, amoxicillin 500 mg, metronidazole 500 mg, and clarithromycin 500 mg along with celecoxib 100 mg (Hakim Company). Control group: In the control group, only the four-drug regimen of Helicobacter pylori including omeprazole 20 mg, amoxicillin 500 mg, metronidazole 500 mg, and clarithromycin 500 mg is prescribed for patients. Gastric metaplasia alleviation. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: endoscopy and biopsy result. Helicobacter pylori eradication. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: endoscopy and biopsy result. Improvement of dyspepsia symptoms. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Dyspepsia symptom assessment questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-03-11 Ethics Committee of Gastroenterology and Liver Research Institute of Shahid Beheshti University of M Arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)