To cpmpare whether adding melatonin or zinc as adjuvant in patients with cirrhosis will decrease the sleep disorder.
Design
Design of the study is a double-blind, randomized control single center clinical trial. Patients with age more than 18 years old with diagnosis of cirrhosis and sleep disorder will be enrolled the study. Patients whom are not desired to enroll the study will be excluded.In this research, 42 patients were randomly divided into two intervention 1/2 groups by Microsoft Excel software and a code was allocated to each one of them.
Settings and conduct
This study is conducted as double blinded randomized clinical trial in taleqani hospital participants and researcher all has been blinded. All patients will receive usual medication for treatment of cirrhosis. In addition patients will receive either melatonin 5 mg/night or zinc 30 mg/night randomly. After 4 weeks sleep quantity will be determined in each groups and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with diagnosis of cirrhosis and sleep disorder with obtaining written consent form
Exclusion criteria: sensitivity to melatonin or zinc
Intervention groups
Intervention group 1 (melatonin tablet):cirrhotic patients compatible with inclusion/exclusion criteria administrated with 5 mg melatonin nightly for 8 weeks.
Intervention group 2 (zinc tablet): cirrhotic patients compatible with inclusion/exclusion criteria administrated with 30 mg zinc nightly for 8 weeks.
Main outcome variables
Sleep quantity score on the basis of Pittsburg questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N18
Registration date:2024-07-20, 1403/04/30
Registration timing:prospective
Last update:2024-07-20, 1403/04/30
Update count:0
Registration date
2024-07-20, 1403/04/30
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
2024-08-22, 1403/06/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of melatonin and zinc in optimization of sleep disorder in cirrhotic patients
Public title
Comparison effect of melatonin and zinc in optimization of sleep disorder in cirrhotic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis of cirrhosis on the basis of doing liver biopsy obtaining written informed consent
Exclusion criteria:
Patients with previous history of allergy to melatonin or zinc
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
42
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 melatonin and zinc in same size, shape color, odor and package which organized just by one responsible co-researcher has no involvement in running study.
Placebo
Not 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
2024-06-24, 1403/04/04
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.087
Health conditions studied
1
Description of health condition studied
Patients with diagnosis of cirrhosis
ICD-10 code
K74.60
ICD-10 code description
Unspecified cirrhosis of liver
Primary outcomes
1
Description
assessment of sleep in cirrhotic patienr
Timepoint
4 weeks after starting the treatment
Method of measurement
Pittsburg questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Addition of melatonin tablet 5mg nightly to pharmacologic regimen for 4 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Addition of zinc tablet 30 mg nightly to pharmacologic regimen for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Talighani hospital
Full name of responsible person
Mohammad Abbasinazari
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
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
Taeran
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 Pharmacyو 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 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 Pharmacyو 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
Mohammad Abbasinazari
Position
full professor
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
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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after deidentified
When the data will become available and for how long
starting in ِJuly 2025
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
with written consent
From where data/document is obtainable
Sending email to: m_abbasi@sbmu.ac.ir
What processes are involved for a request to access data/document