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IRCT20201116049400N1 IRCT 2021-07-30 Esfahan University of Medical Sciences The effect of eradication of Helicobacter pylori infection in the treatment of rosacea HP Evaluation of the treatment of rosacea patients after eradication of Helicobacter pylori infection and treatment with topical gel of metronidazole 75% in comparison with control. 2021-07-23 anticipated 120 Complete https://irct.ir/trial/52344 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirmation of Helicobacter pylori infection in patients with rosacea, they are divided into two groups based on restricted simple randomization of block randomization.: group 1 (intervention) and group 2 (comparison). Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to ensure that the number of samples assigned to each of the study groups is equal in cases where intermediate analyzes are required during the sampling process. The size of all blocks is equal and in this two-group experiment ,we will have 20 blocks (including 3 participants in the intervention group and 3 participants in the control group). For randomization tools, random allocation software is used. These random sequence generation software, in addition to simple randomization, are able to generate random sequences by blocking method. 3 Rosacea. Intervention 1: Intervention group: In addition to the standard treatment with Metro Nidazole 75% topical gel (Metromax produced by Tehran Shimi Company) (twice a day), in order to eradicate the infection for two weeks, triple antibiotic treatment with clarithromycin 500 mg (twice a day) (Pharmacy Laboratory) Day of medicine), amoxicillin 1 g (twice a day) (Kosar Pharmaceutical Company) and omeprazole 20 mg (twice a day) (Sanamad Pharmaceutical Company) are applied. Intervention 2: Control group: In the case of the comparison (control) group, treatment with topical metronidazole 75% gel (twice daily) (Metromax produced by Tehran Shimi Company) will be prescribed. 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 There is no need to share people's information.
public Dr. Seyed Hossein Hejazi
Hezar Jarib Street, Isfahan University Of Medical Sciences
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶ +98 31 3792 9173 hejazi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Seyed Hossein Hejazi
Hezar Jarib Street, Isfahan University Of Medical Sciences
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶. +98 31 3792 9173 hejazi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 17-56 Subjects with rosacea 17 years 65 years Both Gastrointestinal symptoms (bloating, nausea, high intestinal upset, premature satiety, heartburn, ...) Age less than 17 and more than 65 years Antibiotics ( Bismuth subsalicylate) for the treatment of Helicobacter pylori eradication Use of proton pump inhibitors (Nexium and Prilosec) during the month before the start of the study Pregnancy or Breastfeeding L71 Rosacea Treatment - Drugs Treatment - Drugs Intervention group: In addition to the standard treatment with Metro Nidazole 75% topical gel (Metromax produced by Tehran Shimi Company) (twice a day), in order to eradicate the infection for two weeks, triple antibiotic treatment with clarithromycin 500 mg (twice a day) (Pharmacy Laboratory) Day of medicine), amoxicillin 1 g (twice a day) (Kosar Pharmaceutical Company) and omeprazole 20 mg (twice a day) (Sanamad Pharmaceutical Company) are applied. Control group: In the case of the comparison (control) group, treatment with topical metronidazole 75% gel (twice daily) (Metromax produced by Tehran Shimi Company) will be prescribed. Determination of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) levels of Helicobacter pylori and qualitative determination of Helicobacter pylori antigens. Timepoint: Measurement of IgG and IgM levels of Helicobacter pylori , evaluation of the presence of Helicobacter pylori antigen in the feces of patients and lesion size (before the intervention) and 2 months after the start of topical antibiotics and gels. Method of measurement: ELISA (Enzyme-Linked Immunosorbent Assay), EIA (Enzyme Immunoassay). Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2020-11-01 Ethics Committee Of Isfahan University Of Medical Sciences Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)