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IRCT20190602043787N1 IRCT 2019-08-09 Mashhad University of Medical Sciences Triple-blind clinical trial on the effect of a combination of garlic, silymarin and curcumin in comparison with placebo in the treatment of non-alcoholic fatty liver disease GSC in NAFLD Triple-blind clinical trial on the effect of a combination of garlic, silymarin and curcumin in comparison with placebo in the treatment of non-alcoholic fatty liver disease 2019-07-01 anticipated 60 Complete https://irct.ir/trial/40018 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were devided to two groups by simple randomization through random number table that produced from PASS software. patients were randomized to receive drug (case) or matched-placebo(control) , Blinding description: patients were cured by healthcare providers with drug packages that coded and blinded for patients,analyzers,data collectors, outcome assessors by triple-blind trial .only main researcher get informed about contents of packages and coding.patients were followed by codes. For the control group, placebo was prescribed in the shape and color and size of the drug. 2-3 fatty liver disease. Intervention 1: Intervention group:The intervention group received routine treatment with low intake of carbohydrate and fat with the administration of curcumin. garlic, silymarin in Soft gel , will be gave to patients for three months.curcumin has gave from curcumin plant and concentrated with HPLC,garlic and silymarin dried up then filled in capsules. Intervention 2: Control group: In this group, the placebo contains inert oil, with the same color as the drug that the drug manufacturer has produced, was given to patients with nonalcoholic fatty liver disease for a period of three months, in terms of shape and size, similar to the medicine. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is the patients information is secret. for publition will be decided in future.
public Zahra Ataee
Emam Reza Hospital.Emam Reza Ave.
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 zahraataee57@gmail.com Mashhad University of Medical Sciences scientific Hooman Mosannen Mozaffari
Emam Reza Hospital,Emam Reza Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 Mozaffarih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) increased LFT plus sonographic evidenses of NAFLD age between 18-70 years 18 years 70 years Both diabetes mellitus hypothyioidism any drug users sever cardiac disease or sever polmunary disease or past medical history of liver disease,cirrhosis,cancer pregnancy and lactation abnormal test include:ANA,HCV Ab,HBC Ab,HBS Ag,Anti TTG IgA,TIBC,Ferritin,SI,ASMA,seroloplasmin K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group:The intervention group received routine treatment with low intake of carbohydrate and fat with the administration of curcumin. garlic, silymarin in Soft gel , will be gave to patients for three months.curcumin has gave from curcumin plant and concentrated with HPLC,garlic and silymarin dried up then filled in capsules. Control group: In this group, the placebo contains inert oil, with the same color as the drug that the drug manufacturer has produced, was given to patients with nonalcoholic fatty liver disease for a period of three months, in terms of shape and size, similar to the medicine. 1.decrease in serum level of ALT. Timepoint: at the baseline and 3 months after intervention. Method of measurement: autoanalyzer bt3000. Decrease in ultrasonographic grading. Timepoint: at the baseline and 3 months after intervention. Method of measurement: ultrasonography. Mashhad University of Medical Sciences Approved 2019-05-26 Ethics committee of Mashhad University of Medical Sciences Emam Reza Hospital.Emam Reza Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)