The main target of the study is to determine and compare the effect of Fluoxetine 20 mg/day with safron 15 mg/day on symptoms of patients with moderate to severe irritable bowel syndrome. 50 patients with moderate to severe irritable bowel syndrome who refer to Gastero-intestinal clinic of Imam Khomeini hospital (Tehran, Iran) will be recruited if meet the eligibility criteria. The patients will be randomly assigned into one of the following groups to receive Fluoxetine 20 mg/day or safron 15 mg/day, for 6 weeks. The severity of symptoms,will be measured at the baseline and second, 4th and 6th week after the intervention. Symptoms will also be registered daily. The follow-up period will be 6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509081556N81
Registration date:2015-09-16, 1394/06/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Saffron vs Fluoxetine in irritable bowel syndrome patients: A double – blind controlled clinical trial
Public title
Saffron in irritable bowel syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 years old; IBS diagnosis through ROME III criteria; moderate to severe symptoms through severity of symptom questionnaire. Exclusion criteria: diagnosis of any organic disease related to symptoms during the study; psychological disorders taking any other psychotropic drugs during 4 weeks before entering to the trial; history of taking fluoxetine for treatment of IBS in the past; presence of any contraindications for taking fluoxetine; low compliance; severe complications due to fluoxetine; pregnancy or breastfeeding at the beginning or during the trial.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
IR.TUMS.REC.1394.670
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Severity of symptom
Timepoint
Baseline and weeks 2-4-6 after beginig of treatment
Method of measurement
IBS-SSS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Capsule Saffron 15mg/day as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Capsule Fluoxetine 20 mg/day for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Prof. Reza Malekzadeh
Street address
Keshavarz blvd. Imam Khomeini Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar Street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 8898 7381
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar Street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 8898 7381
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)