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IRCT2017081435691N1 IRCT 2017-09-07 Isfahan University of Medical Sciences Therapeutic effects of low-dose Bismuth subcitrate on symptoms and health-related quality of life in adult patients with irritable bowel syndrome: A clinica ltrial Therapeutic effects of low-dose Bismuth subcitrate on symptoms and health-related quality of life in adult patients with irritable bowel syndrome: A clinical trial 2015-06-21 anticipated 120 Complete https://irct.ir/trial/26902 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Condition 1: Irritable bowel syndrome. Condition 2: Irritable bowel syndrome with diarrhea. Condition 3: Irritable bowel syndrome without diarrhea. Intervention 1: The pharmacotherapy regimen for the intervention group was mebeverine hydrochloride 200 mg capsule once daily ( before breakfast ) and bismuth subcitrate 120 mg tablet twice daily (30 min before breakfast and dinner). Intervention 2: For the placebo group,mebeverine hydrochloride 200mg capsule once daily(before breakfast) and placebo of bismuth subcitrate(that did not have any effective material) 120 mg tablet twice daily(30 min breakfast and dinner meal)was were given.
public Dr.Hamed Daghaghzadeh
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3669 3880 daghaghzadeh@med.mui.ac.ir Isfahan University of Medical Sciences scientific Dr.Payman Adibi
School of Medicine, Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3669 3880 adibi@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Diagnosis irritable bowel syndrome based on Rome 3 criteria; age>18 ; both sex. Exclusion criteria:age<18 and age>70 ; pregnancy; having a documented chronic heart or liver failure; surgery on the gastrointestinal tract except appendectomy; malabsorption diseases; hyperthyroidism; inflammatory bowel diseases; connective tissue diseases; severely progressive diseases, diabetes mellitus; use of antibiotic drugs within a month before the study; significant weight loss; fever; and bloody stools. 18 years 70 years Both k58 k58.0 k58.9 irritable colon Irritable bowel syndrome with diarrhea Irritable bowel syndrome without diarrhea Treatment - Drugs Treatment - Drugs The pharmacotherapy regimen for the intervention group was mebeverine hydrochloride 200 mg capsule once daily ( before breakfast ) and bismuth subcitrate 120 mg tablet twice daily (30 min before breakfast and dinner). For the placebo group,mebeverine hydrochloride 200mg capsule once daily(before breakfast) and placebo of bismuth subcitrate(that did not have any effective material) 120 mg tablet twice daily(30 min breakfast and dinner meal)was were given Quality of life. Timepoint: 4 month wth monthly follow up. Method of measurement: IBS-qol questionare. Bloating. Timepoint: 4 month wth monthly follow up. Method of measurement: questionare. Abdominal pain. Timepoint: 4 month wth monthly follow up. Method of measurement: Questionare. Satisfaction of defication. Timepoint: 4 month wth monthly follow up. Method of measurement: Questionare. Ibs duration. Timepoint: 4 month wth monthly follow up. Method of measurement: questionare. Age. Timepoint: 4 month wth monthly follow up. Method of measurement: Questionare. Sex. Timepoint: 4 month wth monthly follow up. Method of measurement: Questionare. Isfahan University of Medical Sciences Approved 2015-08-01 Isfahan Regional Bioethics Committee Isfahan University of Medical Sciences isfahan Iran (Islamic Republic of)