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IRCT20220104053626N6 IRCT 2023-10-19 Tabriz University of Medical Sciences The effect of mast cell stabilizers on non-alcoholic fatty liver Effect of mast cell stabilizers on elastographic findings of patients with nonalcoholic fatty liver disease 2023-11-22 anticipated 50 Complete https://irct.ir/trial/72965 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Non-alcoholic fatty liver disease. Intervention 1: 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 . Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Masood Faghih Dinevari
Internal medicine department, Emam reza hospital, Golgasht avenue, Daneshgah street
Tabriz Iran (Islamic Republic of) 5164886994 +98 41 3334 7054 dinvarim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masoud Faghih Dinevari
Emam Reza Hospital, Golgasht Ave.
Tabriz Iran (Islamic Republic of) 5174666994 +98 41 3337 2084 masood.dinevari@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 59 years Willingness to participate in the study No history of alcohol consumption Do not take drugs with liver toxicity 18 years 59 years Both 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 K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo 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 . 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 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. 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. Tabriz University of Medical Sciences Approved 2023-09-18 Ethics committee of Tabriz University of Medical Sciences Ethic committee,vice chancellor for research,faculty of medicine,Tabriz university of Medical sciences,Golgasht Ave,Tabriz,Iran Tabriz East Azarbaijan Iran (Islamic Republic of)