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IRCT20121216011763N54 IRCT 2022-03-28 Esfahan University of Medical Sciences Curcumin-piperine supplementation in children with none- alcoholic fatty liver disease ندارد The effect of curcumin-piperine supplementation on inflammatory and oxidative stress factors, sonographic findings and symptom of depression, anxiety and stress in children with nonalcoholic fatty liver disease 2022-03-12 anticipated 60 Complete https://irct.ir/trial/62413 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner. https://www.sealedenvelope.com/simple-randomiser/v1/lists In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age and sex. It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it, Blinding description: In this study, children will not be aware of received intervention. Furthermore, before the beginng of intervention, curcumin supplements and their placebo which are completely similar to each other, will be coded to A and B by a third person rather than main researcher to keep blindness of study. 3 None- alcoholic fatty liver disease. Intervention 1: Intervention group: Take one capsule containing curcumin piperine daily (containing 500 mg curcumin extract and 5 mg piperine, Sami labs Ltd., India ) for 10 weeks. Intervention 2: Control group: They will receive one placebo capsule (500 mg of maltodextrin, Sami labs Ltd., India ) daily for 10 weeks. 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 No further information
public Gholamreza Askari
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Gholamreza Askari
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children with non alcoholic fatty liver disease Age 10-18 years old 10 years 18 years Both Presence of hepatitis, Chronic liver disease , Cardiovascular, Renal, Pulmonary, Hypothyroidism diseases and cancer Not consuming drugs that could affect on Alanine aminotransferase level including HMG-COA reductase inhibitors, metformin K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Take one capsule containing curcumin piperine daily (containing 500 mg curcumin extract and 5 mg piperine, Sami labs Ltd., India ) for 10 weeks. Control group: They will receive one placebo capsule (500 mg of maltodextrin, Sami labs Ltd., India ) daily for 10 weeks. C-reactive protein. Timepoint: At the beginning of study - week 10. Method of measurement: Biochemical assessment. Total antioxidant capacity. Timepoint: At the beginning of study - week 10. Method of measurement: Biochemical assessment. Total oxidant status. Timepoint: At the beginning of study - week 10. Method of measurement: Biochemical assessment. Oxidative stress index. Timepoint: At the beginning of study - week 10. Method of measurement: Biochemical assessment. Sonographic findings. Timepoint: At the beginning of study - week 10. Method of measurement: Liver ultrasonography. Esfahan University of Medical Sciences Approved 2021-09-05 Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)