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IRCT20180802040678N2 IRCT 2019-08-13 Tabriz University of Medical Sciences Effect of piperine supplement in patients with non alcoholic fatty liver disease Investigation of the effect of piperine supplement on anthropometric indices, ultrasonographic findings, biochemical parameters and quality of life in patients with nonalcoholic fatty liver disease 2019-08-11 anticipated 64 Complete https://irct.ir/trial/41203 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomizing by computer software, Blinding description: Participants-healthcare provider-data collectors. 3 Non-Alcoholic Fatty Liver Disease. Intervention 1: Intervention group: Administration of Piperine 5mg supplement daily for three months. Intervention 2: Control group: Administration of placebo for three months. Yes - There is a plan to make this available What will be shared: Information about the study is available upon approval by the University's Ethics Committee. When: Starting access 6 months after publication of data To whom: Everybody Conditions: Using is not authorized Where to obtain: Applicants must send their request to the author How to obtain: Sending the request via e-mail Comments:
public Masoud Nouri-Vaskeh
Golgasht Ave.
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 3325 9778 mnvaske@gmail.com Tabriz University of Medical Sciences scientific Leila Alizadeh
Golgasht Ave.
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41333354844 alizadele@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Grade 2 and 3 non-alcoholic fatty liver ALT levels upper than 1.5 times the normal upper limit 18 years no limit Both Chronic liver disease, diabetes, malignancy, hereditary diseases that affect the liver such as iron and copper storage disorder, untreated hypothyroidism, autoimmune disease, pregnancy, lactation, alcoholic fatty liver disease, consumption Alcohol, hepatitis Hypolipidemic and anti-inflammatory agents Bariatrics surgery in last year 43/5000Heavy diet to lose weight in the last 3 months Increase in fatty liver grade grade based on ultrasonographic findings during the study period Weight loss more than 10% during the study Discontent to continuation the study Not taking more than 10% of supplement K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Administration of Piperine 5mg supplement daily for three months Control group: Administration of placebo for three months Fattly Liver Grading. Timepoint: Before and after intervention. Method of measurement: Ultrasonography. Quality of Life. Timepoint: Before and after intervention. Method of measurement: SF-36, CLDQ, and Disease Symptom Index 2.0 questionnaires. Anthropometric indices. Timepoint: Before and after intervention. Method of measurement: Body weight and Body Mass Index. Biochemical parameters. Timepoint: Before and after intervention. Method of measurement: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Bilirubin Total and Direct, Fasting Blood Suger, Triglyceride, LDL, HDL, VLDL, Hs-CRP, Total Cholesterol, Albumin, Count Blood Cells, HbA1C, HOMA-IR, Fecal Calprotectin. Tabriz University of Medical Sciences Approved 2019-06-17 Ethics Committee of Tabriz University of Medical Sciences Golgasht Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)