Effect of mast cell stabilizer on elastographic findings of patients with nonalcoholic fatty liver disease
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 patients. Patients were randomly divided 2 group by block randomization.
Settings and conduct
Participants will be selected from patients with non-alcoholic fatty liver disease referred to the gastrointestinal clinics of Imam Reza Hospital. General information of patients will be extracted using a questionnaire. All patients will also undergo elastography. First group will be given the drug Ketotifen 1mg twice a day for 6 months. The control group will also take a placebo drug in addition to Will receive their usual. After completing 6 months of treatment, patients will undergo elastography again and the degree of stasis and liver fibrosis will be determined based on LSM and CAP criteria. Pre- and post-intervention findings will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 59 years old; no history of alcohol; do not take drugs with liver toxicity. Exclusion criteria: liver disease with specific etiologies such as viral hepatitis; Cirrhosis; pregnancy or lactation; use anti histamine or anti cholinergic; use alcohol; uncontrolled diabetes.
Intervention groups
Case group will take Ketotifen 1 mg 2 times a day for 6 months. The control group will receive starch capsules with this pattern.
Main outcome variables
Hepatic steatosis and fibrosis indices in patients with non-alcoholic fatty liver disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053626N6
Registration date:2023-10-19, 1402/07/27
Registration timing:prospective
Last update:2023-10-19, 1402/07/27
Update count:0
Registration date
2023-10-19, 1402/07/27
Registrant information
Name
Masood Dinevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dinvarim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mast cell stabilizers on elastographic findings of patients with nonalcoholic fatty liver disease
Public title
The effect of mast cell stabilizers on non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 59 years
Willingness to participate in the study
No history of alcohol consumption
Do not take drugs with liver toxicity
Exclusion criteria:
Having liver disease with specific etiologies such as viral hepatitis
Alcohol consumption
Pregnancy and lactation
Take other drugs anti histamine or anti cholinergic
Cirrhosis of the liver
Uncontrolled diabetes
Age
From 18 years old to 59 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
From the patients who volunteered to participate in the study, 60 persons will be selected by simple random sampling. Randomization method: Randomization unit block: Individual Randomization layers: In each block, people will be matched based on age and gender. Random Allocation software: Random Allocation software How to create a random sequence: Using Random Allocation software Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of drugs received. drugs will be provided to patients by another person who has no role in completing the questionnaire and performing blood tests. Patients will also be informed of the existence of two types of drugs (ketotifen and placebo) when obtaining consent, but will be unaware of which study groups they will be included in. Placebo tablet are similar in appearance, color, and size to ketotifen tablet.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethic committee,vice chancellor for research,faculty of medicine,Tabriz university of Medical sciences,Golgasht Ave,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Approval date
2023-09-18, 1402/06/27
Ethics committee reference number
IR.TBZMED.REC.1402.443
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Hepatic steatosis elastographic index in patients with non-alcoholic fatty liver disease
Timepoint
Before and after the intervention
Method of measurement
CAP index in liver elastography
2
Description
Hepatic fibrosis elastographic index in patients with non-alcoholic fatty liver disease
Timepoint
Before and after the intervention
Method of measurement
LSM index in liver elastography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to their usual medications, Ketotifen 1mg tablets ( manufactured by Alhavi pharmaceutical company) will receive 2 times a day for 6 months .
Category
Treatment - Drugs
2
Description
Control group: In addition to their usual medications, placebo tablets with the same shape and size ( manufactured by Alhavi pharmaceutical company) will receive 2 times a day for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Zahra Mortezapour
Street address
Emam Reza Hospital, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Phone
+98 41 3337 2084
Email
Z.mortezapour1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Vice chancellor for Research,Tabriz University of medical sciences, Golgasht Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3337 2084
Email
shahabi_p@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Masood Faghih Dinevari
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department, Emam reza hospital, Golgasht avenue, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3334 7054
Email
dinvarim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Faghih Dinevari
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5174666994
Phone
+98 41 3337 2084
Email
masood.dinevari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Faghih Dinevari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5174666994
Phone
+98 41 3337 2084
Email
masood.dinevari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD