Purpose: Efficacy of melatonin to improve gastrointestinal symptoms in patients with Irritable Bowel Syndrome (IBS) in comparison with placebo group.
Method: First, among patients who referred to Amir hospital in Arak, IBS patients would be diagnosed by the gastroentrologist, using rome III criteria. Then, the patients randomly will be divided into two group of 32. One group would be administered melatonin and the other group would be administered placebo. Before starting the treatment, for registering essential information, patients should complete a questionnaire designed for this purpose. Treatment of two groups will be continued for 8 weeks, then patients will be recalled and they should complete a questionnaire for other essential information for the study.
Inclusion Criteria: patients with IBS according to rome III criteria; Lack of coincident disease; Not using other therapies for treatment of IBS during last month.
Exclusion Criteria: Non cooperative patients; Substance addicted patients.
Intervention: Information and variables registered in the two questionnaire before and after treatment would be compared and assessed, and the effect of melatonin on patients would be assessed according to gender, age, and symptoms like abdominal pain, bloating and changes in bowel habit.
Main outcome variable: The effect of melatonin on quality of life improvement of IBS patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012532186N1
Registration date:2017-09-24, 1396/07/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-24, 1396/07/02
Registrant information
Name
Hossein Rashvand
Name of organization / entity
Arak medical university
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
h.rashvand@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin treatment in patients with Irritable Bowel Syndrome (IBS)
Public title
The effect of melatonin treatment in patients with Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Irritable Bowel Syndrome (IBS) based on Rome III criteria; Lack of comorbidity including anemia, blood in the stool, significant weight loss, nocturnal diarrhea, Inflammatory Bowel Disease (IBD); previous abdominal surgery; diabetes; thyroid disorders; do not use antibiotic in the last month; do not take drug for IBS treating in the last month.
Exclusion criteria: lack of patient collaboration; drug addiction; any risk of heart disease; neurological and psychological disorder; gastrointestinal and liver disease; pregnancy; any kind of malignancy
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization method is randomized block design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Mailbox646; Allamolhoda St; Shahid Shiroudi St
City
Arak
Postal code
3819693345
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.ARAKMU.REC.1395.147
Health conditions studied
1
Description of health condition studied
Irritabale Bowel Syndrome
ICD-10 code
K58.9, k58
ICD-10 code description
Irritable bowel syndrome with diarrhoea, Irritable bowel syndrome without diarrhoea
Primary outcomes
1
Description
The effect of melatonin on the abdominal pain in patients with irritable bowel syndrome
Timepoint
Before and 8 weeks after receiving a daily dose of 3 mg melatonin
Method of measurement
questionnare
2
Description
The effect of melatonin on the abdominal bloating in patients with irritable bowel syndrome
Timepoint
Before and 8 weeks after receiving a daily dose of 3 mg melatonin
Method of measurement
questionnare
3
Description
The effect of melatonin on the number of bowel movements and stool constipation in patients with irritable bowel syndrome
Timepoint
Before and 8 weeks after receiving a daily dose of 3 mg melatonin
Method of measurement
questionnare
Secondary outcomes
1
Description
The effect of melatonin on the quality of life in patients with irritable bowel syndrome
Timepoint
Before and 8 weeks after taking 3 mg of melatonin tablets
Method of measurement
questionnaire
Intervention groups
1
Description
In intervention group, melatonin would be given to patients in the form of 3 milligram tablets made by Nature Med for 8 weeks.
Category
Treatment - Drugs
2
Description
In control group, placebo would be given to patients in the form of tablets similar to melatonin tablets for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hospital GI Clinic
Full name of responsible person
Hossein Rashvand
Street address
Amir Medical and Educating Center; Basij SQ
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Hossein Rashvand
Street address
Amir Medical and Educating Center; Basij SQ
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak 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
Arak University Of Medical Sciences
Full name of responsible person
Hossein Rashvand
Position
Assistant Professor of Internal Medicine
Other areas of specialty/work
Street address
Amir Medical and Ejucating Center; Basij SQ
City
Arak
Postal code
3848176941
Phone
+98 863417360110
Fax
+98 86 3417 3619
Email
h.rashvand@arakmu.ac.ir; horash64@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of medical sciences
Full name of responsible person
Azim Forozan MD
Position
Subspecialty of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Amir Medical and Ejucating Center; Basij SQ
City
Arak
Postal code
3848176941
Phone
+98 863417360110
Fax
+98 86 3417 3619
Email
a.forozan@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Hossein Rashvand
Position
Assistant Professor of Internal Medicine
Other areas of specialty/work
Street address
Amir Medical and Ejucating Center; Basij SQ
City
Arak
Postal code
3848176941
Phone
+98 863417360110
Fax
+98 86 3417 3619
Email
h.rashvand@arakmu.ac.ir; horash64@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)