The aim of present study is to determine whether adding melatonin tablet to treatment regimen in patients with UC (ulcerative colitis) will improve clinical, biochemical parameters and quality of life
Design
Design of the study is a triple-blind, placebo-controlled, randomized control single center clinical trial. Patients with age more than 20 years old with UC will be enrolled the study. Patients whom are not desired to enroll the study will be excluded.In this research, 40 eligible patients with UC 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 triple blinded randomized clinical trial in taleqani hospital participants, researcher & statistical data analyzer all has been blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: uc Age more than 20 years old Exclusion criteria: History of confirmed hypersensitivity reaction to melatonin or any parts of formulation eGFR less than 30 ml/min/1.73m2 Liver failure (child pugh B, C) Pregnancy & lactation Uncontrolled seizure & untreated major depressive disorder Concurrent use of fluvoxamine , nifedipine & NSAID
Intervention groups
Intervention group (melatonin supplement): UC patients compatible with inclusion/exclusion criteria on UC treatment regimens administrated with 3 mg oral melatonin supplement daily for 3 mouths. Control group (melatonin placebo):UC patients patients compatible with inclusion/exclusion criteria on UC treatment regimens administrated with 3 mg oral melatonin placebo daily for 3 mouths.
Main outcome variables
Change in hs-CRP, Hemoglobin& Fecal calprotectin ؛ improvement of quality of life with SF36 index & clinical symptoms with Simple clinical colitis activity index (SCCAI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N9
Registration date:2019-12-03, 1398/09/12
Registration timing:registered_while_recruiting
Last update:2019-12-03, 1398/09/12
Update count:0
Registration date
2019-12-03, 1398/09/12
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
2019-05-22, 1398/03/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of melatonin on clinical, biochemical parameters and quality of life in Ulcerative colitis patients
Public title
The effect of melatonin in Ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
UC disease in patients with more than 20 years old
Exclusion criteria:
History of confirmed hypersensitivity reaction to melatonin or any parts of formulation
eGFR less than 30 ml/min/1.73m2
Liver failure (child pugh B, C)
Pregnancy & lactation
Uncontrolled seizure & untreated major depressive disorder
Concurrent use of fluvoxamine , nifedipine & non steroidal anti inflammatory drugs(NSAID)
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with Microsoft Excel software
Blinding (investigator's opinion)
Triple 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 melatonin in same size, shape color, odor and package with real melatonin tablet 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 school of pharmacy and nursing and midwifery- shahid Beheshti university of medica
Street address
School of Pharmacy, Nyayesh junction, Valiasr street,Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.158
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Change in Fecal calprotectin level
Timepoint
Before intervention and 90 days after initiation of daily use of melatonin
Method of measurement
Lab kits
2
Description
hange in high sensitivity CRP serum level
Timepoint
Before intervention and 90 days after initiation of daily use of melatonin
Method of measurement
Lab kits
3
Description
Change in Hemoglobin level
Timepoint
Before intervention and 90 days after initiation of daily use of melatonin
Method of measurement
Lab kits
4
Description
improvement of clinical symptoms of uc
Timepoint
Before intervention and 90 days after initiation of daily use of melatonin
Method of measurement
Interview with patients based on Simple clinical colitis activity index questionnaire
5
Description
improvement of quality of life
Timepoint
Before intervention and 90 days after initiation of daily use of melatonin
Method of measurement
Interview with patients based on SF36 questionnaire
Secondary outcomes
1
Description
Record of Adverse drug reactions
Timepoint
During intervention
Method of measurement
Interview with patients
Intervention groups
1
Description
Intervention group: Addition of melatonin tablet orally 3 mg/d to UC regimen for 3 months
Category
Treatment - Drugs
2
Description
Control group: Addition of melatonin placebo tablet orally 3 mg/d to UC regimen for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان طالقانی
Full name of responsible person
محمد عباسی نظری
Street address
Valiasr street, nyayesh junction, School of pharmacy
City
Tehrn
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
Nima Naderi
Street address
School of Pharmacy, Nyayesh junction, Valiasr street,
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 9625
Email
naderi@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
roja qobadi ghadikolaei
Position
board certified clinical pharmacist
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
roja.ghobadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
clinical pharmacy specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh 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
Roja Qobadi Ghdikolei
Position
board certified clinical pharmacist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehrn
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
roja.ghobadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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