The aim of present study is to determine whether using sublingual melatonin tablet will improve the quality of life in IBS patients
Design
Design of the study is a triple-blind, placebo-controlled, randomized control single center clinical trial. Patients with age more than 18 years old with IBS will be enrolled the study. Patients whom are not desired to enroll the study will be excluded.In this research, 76 eligible patients with IBS compatible with inclusion criteria were chosen. patients were randomly divided into two control and intervention groups by Microsoft Excel software. and a code was allocated to each one of them.
Settings and conduct
This study is conducted as placebo controlled double blinded randomized clinical trial in taleqani hospital participants and researcher all has been blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: IBS patients with age more than 18 years old
Exclusion criteria: pregnancy and breastfeeding
Intervention groups
Intervention group (sublingual melatonin tablet): IBS patients compatible with inclusion/exclusion criteria administrated with 3 mg sublingual melatonin daily for 8 weeks. Control group (sublingual melatonin tablet placebo): IBS patients compatible with inclusion/exclusion criteria administrated with 1 tablet of placebo daily for 8 weeks.
Main outcome variables
Change in QOL34 score 8 weeks after usage of sublingual melatonin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N14
Registration date:2023-05-29, 1402/03/08
Registration timing:prospective
Last update:2023-05-29, 1402/03/08
Update count:0
Registration date
2023-05-29, 1402/03/08
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Safety of Sublingual Melatonin in alleviation of IBS Symptoms
Public title
Efficacy and Safety of Sublingual Melatonin in alleviation of irratable Bowel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 18 years old with compliant of lower abdominal pain and changes in defecation more than three months
obtaining consent form for entry the study
Exclusion criteria:
Pregnant or breastfeeding women
Patients with Kidney injury (AKIN classification stage 3)
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
1:1 randomization, centralized web-based randomization and according to the entry and exit criteria, through random allocation by balanced block method, individuals are divided into two groups of control and experimental. Using Random Sequence Generator, groups are created and people are placed in one of these two groups based on the reference sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principle investigator, healthcare providers (Physicians, nurses) who care for participants during the trial, data collectors and outcome assessors all are blinded by providing placebo sublingual tablet in same size, shape color, odor and package with sublingual tablet of melatonin which organized just by one responsible co-researcher has no involvement in running study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of pharmacy, nursing and midwifery of Shahid Beheshti university of medical science
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.021
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrom
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Score of quality of life on the basis of IBS-QOL34
Timepoint
Before intervention and 4 weeks after initiation of use of melatonin
Method of measurement
QOL34 questionarre
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sublingual administration of 3 miligram of melatonin daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Sublingual administration of melatonin placebo tablet daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of pharmacy, Shahid Behesti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Street address
valiasr street no 217
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hassan Yazdanpanah
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8866 5282
Email
yazdanpanah@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of PharmacyNyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of PharmacyNyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of PharmacyNyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
for people working in academic institutions
Under which criteria data/document could be used
general use
From where data/document is obtainable
email to: m_abbasi@sbmu.ac.ir
What processes are involved for a request to access data/document