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IRCT20221202056689N1 IRCT 2023-01-25 Ghoum University of Medical Sciences Investigating the effect of quince oxymel on non-alcoholic fatty liver Investigating the therapiotic effect of quince oxymel on treatment of non-alcoholic fatty liver disease - Randomized clinical Trial, triple Blinded, placebo controlled 2023-07-06 anticipated 80 Complete https://irct.ir/trial/67243 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be by block randomization method. For this purpose, the volume of each block is four people, and the number of blocks required for the study is equal to 20 four-person blocks, Blinding description: A special code will be considered for each syrup and this code will be recorded on the syrup label. Only the pharmacist consultant will know about the drug codes. Medicines will be provided to the doctor and plan administrator and the patient. The code of each syrup, specific to each patient, will be inserted in the patient's file and checklist by the administrator. At the end of the study, the information and checklist form of the patients will be provided to the statistics consultant for statistical analysis, and after the data analysis, the code of the syrups will be provided to the administrator and the statistics consultant for the final analysis. syrups in intervention and comparison groups are similar according to color, smell, shape and route of use. 3 Non-alcoholic fatty liver. Intervention 1: Intervention groupPatients with fatty liver referred to the Gastroenterology Specialist Clinic, Doctors City, Qom City are selected according to the entry criteria and randomly divided into intervention and control groups. The patients of the intervention group are treated with ten milliliters of quine oxymel syrup three times a day, half an hour before meals, for twelve weeks. Intervention 2: Control group: Patients with fatty liver referred to the gastroenterology clinic of Gastroenterology Specialist Clinic, Doctors City, Qom City are selected according to the entry criteria and randomly divided into intervention and control groups. Control group patients are treated with ten milliliters of placebo three times a day, half an hour before meals for twelve weeks. The placebo is made in the laboratory of Iranian Medicine Faculty of Qom University. Yes - There is a plan to make this available What will be shared: The data related to the outcome of the study include the changes in the grade of fatty liver in the sonography report and the changes in liver enzymes that can be shared. When: The access period starts 6 months after the results are published To whom: Researchers of academic and scientific institutions Conditions: Use in the treatment of patients and use in scientific articles Where to obtain: Dr. Fatemeh Ali Asl, Assistant Professor, Faculty of Traditional Medicine, Qom University. . Mehrdad Ababaf Shushtri, Ph.D. Specialist Assistant, Faculty of Traditional Medicine, University of Qom. . mehrdadababaf@yahoo,com/.Aliasl1392@gmail.com How to obtain: Send a request by email and receive a response within two working weeks Comments: This study is the first clinical trial to investigate the effect of lemon jelly in the treatment of non-alcoholic fatty liver disease.
public Mehrdad Ababaf Shoushtari
Panzdeh Khordad Blvd., corner of the street - Faculty of Traditional Iranian Medicine
Qom Iran (Islamic Republic of) 3714848350 +98 25 3776 4073 mehrdadbabaf@yahoo.com Ghoum University of Medical Sciences scientific Fatima Ali Asl
Panzdeh Khordad Blvd., corner of 44 St., Faculty of Traditional Iranian Medicine
Qom Iran (Islamic Republic of) 371484850 +98 25 3776 4073 Aliasl1392@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients between the ages of 20 and 65 years are diagnosed with grade 2 or higher fatty liver based on the ultrasound report liver enzymes that are higher than the normal level. 20 years 65 years Both Having diabetes Viral hepatitis and autoimmune hepatitis Having metabolic diseases such as Wilson's disease and hemochromatosis History of alcohol consumption and alcoholic beverages Liver transplant at some point in the past Taking any type of medicine to treat fatty liver in the past one month The patient's unwillingness to continue the plan Severe allergy or drug complication Pregnancy and breastfeeding Taking Varfarin, heparin compounds and anticoagulant drugs K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention groupPatients with fatty liver referred to the Gastroenterology Specialist Clinic, Doctors City, Qom City are selected according to the entry criteria and randomly divided into intervention and control groups. The patients of the intervention group are treated with ten milliliters of quine oxymel syrup three times a day, half an hour before meals, for twelve weeks. Control group: Patients with fatty liver referred to the gastroenterology clinic of Gastroenterology Specialist Clinic, Doctors City, Qom City are selected according to the entry criteria and randomly divided into intervention and control groups. Control group patients are treated with ten milliliters of placebo three times a day, half an hour before meals for twelve weeks. The placebo is made in the laboratory of Iranian Medicine Faculty of Qom University Non-alcoholic fatty liver grade. Timepoint: At the beginning of the study (before the start of the intervention) and twelve weeks after the intervention. Method of measurement: ultrasound device. Alanine aminotransferase enzyme. Timepoint: در ابتدای مطالعه ( قبل از شروع مداخله ) و دوازده هفته بعد از مداخله. Method of measurement: Measuring the serum level of alanine aminotransferase enzyme in peripheral blood samples. Aspartate aminotransferase. Timepoint: در ابتدای مطالعه ( قبل از شروع مداخله ) و دوازده هفته بعد از مداخله. Method of measurement: اندازه گیری سطح سرمی آنزیم آسپارتات آمینو ترانسفراز در نمونه خون محیطی. Ghoum University of Medical Sciences Approved 2022-11-21 Ethics committee of qom University of Medical Sciences No. 83, 4th Alley, Jihad University Street, Safashehr Street, Qom qom Ghoum Iran (Islamic Republic of)