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IRCT2014081518807N1 IRCT 2015-01-12 Vice chancellor for research of Mashhad University of Medical Sciences Effect of Iranian traditional medicine-based diet on Non-alcoholic fatty liver(NAFLD) Effect of Iranian traditional medicine-based diet on Non-alcoholic fatty liver(NAFLD) 2014-10-06 anticipated 100 Complete https://irct.ir/trial/16944 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Non alcoholic fatty liver(NAFLD). Intervention 1: Control group: the detection of Non-alcoholic fatty¬ liver ( NAFLD) by Ultrasound Images (grade 1 or 2 or 3 ) with body mass index(BMI) Less than or equal 27 will be treated with conventional medicine diet, (this treatment consists of feeding a diet low in calories and fat), and (NAFLD) with BMI greater than 27 and less than or equal 30 will be treated with Venostat capsules (500 milligram 2 times a day) and also conventional medicine diet for 3 months. Intervention 2: Intervention group: NAFLD Patients has Body Mass Index (BMI less than 27) treated with diet based on Iranian traditional medicine and NAFLD patient has body mass index (BMI) greater than 27 and less than or equal 30 will be treated with diet based on Iranian traditional medicine and also Hepatomelis (herbal tea consisting of Melissa officinalis and Nigella sativa) twice daily for 3 months.
public Gholam reza Ghayour razmgah
Faculty of Traditional Medicine
Mashhad Iran (Islamic Republic of) +98 51 3855 2188 ghayourgh1@mums.ac.ir Faculty of Traditional Medicine scientific Seyyd Musa Al-Reza Hosseini
Ahmadabad Street, Department of Medicine Internal, Ghaem Hospital,
Mashhad Iran (Islamic Republic of) 9176699199 +98 51138400001 HoseiniMR@mums.ac.ir Department of Medicine Internal Clinic, Ghaem Hospital Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: age 20 to 60 years؛ the detection of Non-alcoholic fatty liver(NAFLD)by Ultrasound Images (grade 1 or 2 or 3 ). Exclusion criteria: diabetes; heart disease; hypertension; over weight(BMI greater than 30 ). familial hyperlipidemia; active alcohol or addiction; discourage patients from continuing to participate in the plan; Breastfeeding; Pregnancy; Any other chronic diseases such as kidney stones, gallstones, cardiovascular surgery; abdominal surgery; CVA; acute hepatitis; acute Pancreatitis; major Surgery during the last 6 months and also any surgery on the liver and gallbladder. Rapid weight loss during the last 3 months for any reason. Drop Out Criteria: Any medication side effects during treatment; Other acute illnesses during the study period who had liver adverse impact on yield: Such as gallstones and surgery and general anesthesia and drugs with liver toxicity; Increase in liver enzymes (AST, ALT) and Fasting blood sugar (FBS) during the study period; Consent to continue participating in the study; Alcohol and alcoholic beverages during the study period; Drug use is incorrect; Failure to follow the prescribed diet; Not see the patient during follow up; pregnancy and breastfeeding women participating in the project. 20 years 60 years Both K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Control group: the detection of Non-alcoholic fatty¬ liver ( NAFLD) by Ultrasound Images (grade 1 or 2 or 3 ) with body mass index(BMI) Less than or equal 27 will be treated with conventional medicine diet, (this treatment consists of feeding a diet low in calories and fat), and (NAFLD) with BMI greater than 27 and less than or equal 30 will be treated with Venostat capsules (500 milligram 2 times a day) and also conventional medicine diet for 3 months. Intervention group: NAFLD Patients has Body Mass Index (BMI less than 27) treated with diet based on Iranian traditional medicine and NAFLD patient has body mass index (BMI) greater than 27 and less than or equal 30 will be treated with diet based on Iranian traditional medicine and also Hepatomelis (herbal tea consisting of Melissa officinalis and Nigella sativa) twice daily for 3 months. Measure levels of liver enzymes (AST , ALT). Timepoint: Before the intervention; 6 weeks after the intervention;End of the intervention (3 months). Method of measurement: Autoanalyzer. Ultrasound Images of liver;Fatty tissue infiltration in liver (grade 1 or 2 or 3 ). Timepoint: Before the intervention;6 weeks after the intervention ;End of the intervention (3 months). Method of measurement: The grading of fatty liver infiltration of fat tissue based on ultrasound by one radiologist. Body mass index (BMI). Timepoint: Before the intervention;6 weeks after the intervention ;End of the intervention (3 months). Method of measurement: Weight and height measurements by one person in the same center. Vice chancellor for research of Mashhad University of Medical Sciences Approved 2014-09-09 Ethics committee of Mashhad University of Medical Sciences Ghoreishi Building, Danehgah Street,Vice chancellor for research, University of Medical Sciences, Mashhad Mashhad Iran (Islamic Republic of)