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IRCT20161205031252N10 IRCT 2018-11-22 Ghoum University of Medical Sciences Effect of dandelion capsule on non-alcoholic fatty liver disease Effect of dandelion capsule on improvement of liver fibrosis and liver function test among patients with non-alcoholic fatty liver disease 2018-11-22 anticipated 50 Complete https://irct.ir/trial/35123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be assigned to two groups of intervention and control by block randomization. For this purpose blocks of size 4 will be used. Six blocks will include BAAB, ABBA, BABA, BBAA, ABAB, AABB. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end, Blinding description: Participants and outcome assessor does not know the allocation. 2-3 Condition 1: Nonalcoholic steatohepatitis. Condition 2: Fatty liver. Intervention 1: Intervention group: Dandelion capsule, 300 mg, oral, twice a day, for 3 months. Intervention 2: Control group: placebo capsule, oral, twice a day, for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not a plan to make this available
public Ahmad Hormati
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
Qom Iran (Islamic Republic of) 3719964797 +98 256122053 Hormatia@muq.ac.ir Ghoum University of Medical Sciences scientific Ahmad Hormati
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2053 Hormatia@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) Grade 2 and 3 of Non-alcoholic fatty liver Hemoglobin above 13 in male and above 12 in female 18 years 65 years Both History of allergy to plants of asteraceae Bile duct or intestinal obstruction Diabetes and renal failure Pregnant and lactating women Weight below 50 kg Consumers of lithium, tetracyclines, fluoroquinolones, blood glucose lowering drugs and blood thinners drugs K75.81 K76.0 Nonalcoholic steatohepatitis (NASH) Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Dandelion capsule, 300 mg, oral, twice a day, for 3 months Control group: placebo capsule, oral, twice a day, for 3 months Liver stiffness. Timepoint: Three months after treatment. Method of measurement: Fibroscan. Blood levels of liver enzymes. Timepoint: Three months after treatment. Method of measurement: Blood test. Ghoum University of Medical Sciences Approved 2018-11-06 Ethics Committee of Qom University of Medical Sciences No. 83, 4th alley, 1.1 alley, Safashahr Blvd Qom Ghoum Iran (Islamic Republic of)