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Register:	IRCT
Last refreshed on:	22 February 2018
Main ID:	IRCT2017081435691N1
Date of registration:	2017-09-07
Prospective Registration:	No
Primary sponsor:	Isfahan University of Medical Sciences
Public title:	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
Scientific title:	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
Date of first enrolment:	2015-06-21
Target sample size:	120
Recruitment status:	Complete
URL:	http://en.irct.ir/trial/26902
Study type:	interventional
Study design:	Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
Phase:	3

Countries of recruitment
Iran (Islamic Republic of)

Contacts

Name:	Dr.Payman Adibi
Address:	School of Medicine, Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan Isfahan Iran (Islamic Republic of)
Telephone:	+98 31 3669 3880
Email:	adibi@med.mui.ac.ir
Affiliation:	Isfahan University of Medical Sciences

Name:	Dr.Hamed Daghaghzadeh
Address:	Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan Isfahan Iran (Islamic Republic of)
Telephone:	+98 31 3669 3880
Email:	daghaghzadeh@med.mui.ac.ir
Affiliation:	Isfahan University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria:

Age minimum: 18 years
Age maximum: 70 years
Gender: Both

Health Condition(s) or Problem(s) studied

Condition 1: Irritable bowel syndrome. Condition 2: Irritable bowel syndrome with diarrhea. Condition 3: Irritable bowel syndrome without diarrhea.
irritable colon
Irritable bowel syndrome with diarrhea
Irritable bowel syndrome without diarrhea

Irritable bowel syndrome without diarrhea

Irritable bowel syndrome with diarrhea

irritable colon

Intervention(s)

Treatment - Drugs

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

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 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.

Primary Outcome(s)

Abdominal pain. Timepoint: 4 month wth monthly follow up. Method of measurement: Questionare.

Bloating. 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.

Quality of life. Timepoint: 4 month wth monthly follow up. Method of measurement: IBS-qol questionare.

Age. Timepoint: 4 month wth monthly follow up. Method of measurement: Questionare.

Ibs duration. Timepoint: 4 month wth monthly follow up. Method of measurement: questionare.

Sex. Timepoint: 4 month wth monthly follow up. Method of measurement: Questionare.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Isfahan University of Medical Sciences

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Isfahan Regional Bioethics Committee

Results

Results available:
Date Posted:
Date Completed:
URL:

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