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IRCT20181023041431N1 IRCT 2019-03-09 Mashhad University of Medical Sciences Effectiveness of Ciochorium intibus syrup on non-alcoholic fatty liver Evaluation of the effect of Ciochorium intibus syrup on clinical and para clinical manifestations of patients with non-alcoholic fatty liver 2019-03-11 anticipated 100 Complete https://irct.ir/trial/37590 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be based on a random allocation table provided by a computer. In order to conceal the random allocation of the groups, sealed envelopes will be used. Then, the envelopes are opened in sequence for each patient and the method of treatment becomes known, Blinding description: This is a single-blind study in which the participants are unaware of their treatments, and the type of drug treatment is based on sealed envelopes. 3 non-alcoholic fatty liver. Intervention 1: Intervention group: Patients are treated with Ciochorium intibus syrup for two months, receiving 8 cc of the syrup three times a day, half an hour before each meal. Metformin is also given as the common drug. Intervention 2: Control group: The control group receives placebo syrup. Metformin is also given as the common drug. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Dr Seyed Mousareza Hoseini
Ghaem Hospital, Ahmad Abad Avenue
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2742 hoseinimr@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Seyed Mousareza Hoseinin
Ghaem Hospital, Ahmad Abad Avenue
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2742 HoseiniMR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age of over 20 and below 60 Higher than 40 alanine aminotransferase and aspartate aminotransferase serum levels Fatty liver with grade 2 and higher Body mass index of over 27 20 years 60 years Both Pregnancy and breastfeeding Use of alcohol Previous history of confirmed liver diseases Use of any diet or drug for the treatment of fatty liver within the last 3 months Confirmed autoimmune diseases All types of malignancy K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Patients are treated with Ciochorium intibus syrup for two months, receiving 8 cc of the syrup three times a day, half an hour before each meal. Metformin is also given as the common drug. Control group: The control group receives placebo syrup. Metformin is also given as the common drug. Serum level of alanine aminotransferase. Timepoint: At the beginning of the study (before the intervention) and at the end of the intervention. Method of measurement: Biochemical tests. Serum level of aspartate aminotransferase. Timepoint: At the beginning of the study (before the intervention) and at the end of the intervention. Method of measurement: Biochemical tests. Change in fatty liver grade. Timepoint: Before and after intervention. Method of measurement: Sonography. Mashhad University of Medical Sciences Approved 2018-04-11 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)