Clinical Trial Details

Trial ID: L0381
Source ID: IRCT20170628034786N4
Associated Drug: Curcumin
Title: Evaluation of the effectiveness of Curcumin on fatty liver disease in children
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: NAFLD. <br>Fatty (change of) liver, not elsewhere classified;K76.0
Interventions: Intervention 1: Intervention group: Patients will receive a 40 or 80 mg nanomicelle sina curcumin soft gel daily for 8 weeks. Intervention 2: Control group: The placebo will be taken once a day , which is quite similar in color and size to the main medici
Outcome Measures: Serum level of Alanine aminotransferase. Timepoint: 8 weeks after the initiation of treatment. Method of measurement: Quantitative measurement of liver transaminase.;Serum level of Aspartate aminotransferase. Timepoint: 8 weeks after the initiation of treatment. Method of measurement: Quantitative measurement of liver transaminase.Body mass index. Timepoint: Before the intervention, 8 weeks after the initiation of treatment. Method of measurement: Measurement of height and weight and ratio of weight to square of height.;Fasting Blood Sugar. Timepoint: Before the intervention, 8 weeks after the initiation of treatment. Method of measurement: Quantitative measurement of serum Fasting Blood Sugar.;Lipid profile(Chol,TG,HDL,LDL). Timepoint: Before the intervention, 8 weeks after the initiation of treatment. Method of measurement: Quantitative measurement of serum lipid profile(Chol, TG, HDL,LDL).;Alkaline phosphatase. Timepoint: Before the intervention, 8 weeks after the initiation of treatment. Method of measurement: Quantitative measurement of serum Alkaline phosphatase.
Sponsor/Collaborators: Esfahan University of Medical Sciences
Gender: All
Age: 5 years16 years
Phases: Phase 3
Enrollment: 60
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: During random allocation, patients will be divided into two groups of interventional and placebo by permutation block
Start Date: 04/07/2021
Completion Date: --
Results First Posted: --
Last Update Posted: 12 July 2021
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/57015