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IRCT20100524004010N35 IRCT 2023-02-08 Shahid Beheshti University of Medical Sciences Evaluation of the effects of ginger consumption on eradication of H.pylori, clinical symptoms, inflammatory factors, and oxidative stress in patients with peptic ulcer Evaluation of the effects of ginger consumption on eradication of H.pylori, clinical symptoms, inflammatory factors, and oxidative stress in patients with peptic ulcer 2023-02-08 anticipated 42 Complete https://irct.ir/trial/68230 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomized into ginger group or placebo according to the table of random numbers at the beginning of the study, Blinding description: Patients won’t know if they are receiving the ginger or a placebo tablets and for double-blinding the study, the bottles containing the relevant tablets will be concealed as A and B by a third person at the beginning of the study, and none of the research team members will know the type of tablets received by each group. 2 Peptic ulcer. Intervention 1: Intervention group: will take 2g of ginger daily in the form of four tablets each contains 500 mg of ginger (Product of Dine Company) orally for six weeks. Intervention 2: Control group: will take four placebo tablets daily, which are similar in shape and taste to ginger tablet,orally for 6 weeks. 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 We have not yet decided how to share the final data.
public Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) General desire to practice the study Age over 18 years and less than 80 years Confirmation of H. pylori infection by stool antigen test or endoscopic pathology findings No antibiotic use in the last 4 weeks No active alcohol consumption or alcohol, corticosteroid and anticoagulant use No diseases Cardiovascular, liver, lung, kidney, malignancy Absence of recent surgery Absence of pregnancy or breastfeeding in women Absence of allergy to H pylori infection eradication regimen 18 years 80 years Both Unwilling to continue the study Any allergic reaction to the supplements Consumption of less than 90% of supplements at the end of the study period K27 Peptic ulcer, site unspecified Other Placebo Intervention group: will take 2g of ginger daily in the form of four tablets each contains 500 mg of ginger (Product of Dine Company) orally for six weeks. Control group: will take four placebo tablets daily, which are similar in shape and taste to ginger tablet,orally for 6 weeks H.Pylori eradication. Timepoint: 8 week. Method of measurement: Endoscopy and Pathology. Clinical Symptoms. Timepoint: 8 week. Method of measurement: Questionnaire. Anti-oxidant status. Timepoint: 8 week. Method of measurement: ELISA. Shahid Beheshti University of Medical Sciences Approved 2023-01-21 Ethics committie of the National Institute of Research and Food Industry NO.7,West Arghavan Ave.,Farahzadi Blvd.,Qods Town Tehran Tehran Iran (Islamic Republic of)