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IRCT20190714044196N1 IRCT 2019-07-31 Rafsanjan University of Medical Sciences The effect of hydroalcoholic extract of Berberis fruits integerrima on the lipid profile, antioxidantparameters and liver and kidney function tests in patients with nonalcoholic fatty liver disease The effect of hydroalcoholic extract of Berberis fruits integerrima on the lipid profile, antioxidantparameters and liver and kidney function tests in patients with nonalcoholic fatty liver disease 2017-10-17 anticipated 42 Complete https://irct.ir/trial/40780 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients separated to two groups, randomly using table of random numbers, Blinding description: Participant (patients), care provider and data analyser have no information about the type of treatment substance. 3 Nonalcoholic fatty liver. Intervention 1: Intervention group: received a gelatin capsule contain 750 mg hydro-alcoholic extract of Berberis integerrima . Berberis fruits were taken from mountainous areas of Bardsir, Kerman, Southeast of Iran and confirmed by Iranian institute of research & development in chemical industries and they were extracted in that institute. Intervention 2: Control group: received a gelatin capsule contain 750 mg cellulose every 12 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mehdi Afshari
Department of Biochemistry, Rafsanjan University of Medical Sciences
Rafsanjan Iran (Islamic Republic of) 7718134567 +98 34 3131 5175 mehdi.af.1372@gmail.com Rafsanjan University of Medical Sciences scientific Mehdi Afsahri
Department of Biochemistry, Rafsanjan University of Medical Sciences
Rafsanjan Iran (Islamic Republic of) 7718134567 +98 34 3131 5175 mehdi.af.1372@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Suffering from nonalcoholic fatty liver Elevated levels of Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Age range of 20-45 years old Signing a declaration of consent 20 years 45 years Both Using alcohol Using daily berberis Having allergy to berberis and its compounds, Patients with diabetes High blood pressure Patient with perceptual disorders Nephrotic syndrome Ischemic heart diseases Patient with chronic liver disease such as hepatitis Pregnancy or lactation K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: received a gelatin capsule contain 750 mg hydro-alcoholic extract of Berberis integerrima . Berberis fruits were taken from mountainous areas of Bardsir, Kerman, Southeast of Iran and confirmed by Iranian institute of research & development in chemical industries and they were extracted in that institute. Control group: received a gelatin capsule contain 750 mg cellulose every 12 hours Fasting blood glucose. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Total cholesterol. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Triglyceride. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. LDL-C. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. HDL-C. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Alanine aminotransferase. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Aspartate aminotransferase. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Alkaline phosphatase. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Total bilirubin. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. And direct bilirubin. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Urea. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Creatinine. Timepoint: Before and after treatment. Method of measurement: measured using Pars azmun kit. Glutathione peroxidase enzyme. Timepoint: Before and after treatment. Method of measurement: ZellBio kit. Malondialdehyde. Timepoint: Before and after treatment. Method of measurement: ZellBio kit. Total antioxidant. Timepoint: Before and after treatment. Method of measurement: ZellBio kit. Blood pressure. Timepoint: Before and after treatment. Method of measurement: Blood pressure monitor. Rafsanjan University of Medical Sciences Approved 2017-10-17 Ethics Council of Rafsanjan University of Medical Sciences Rafsanjan University of Medical Sciences, Department of Biochemistry Rafsanjan Kerman Iran (Islamic Republic of)