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IRCT20210427051098N2 IRCT 2023-04-20 Yazd University of Medical Sciences The effect of Nanocurcumin on liver fibrosis Investigating the effects of Nanocurcumin supplementation on fibrosis، steatosis، Inflammatory and metabolic status of liver fibrosis patients with non-alcoholic fatty liver origin 2023-04-20 anticipated 50 Complete https://irct.ir/trial/68236 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 50 patients with liver fibrosis, who have inclusion criteria and do not have exclusion criteria, based on a pre-designed random list (the list will be designed through the website https://www.sealedenvelope.com/simple-randomiser/v1/lists) ) will be randomly assigned to two groups to receive curcumin or placebo. Each drug package is assigned a code, the codes will be A and B. To reduce the bias in placing people in the treatment or placebo groups, patients will be randomly assigned to one of the two nanocurcumin or placebo groups using the blocked randomization method (the size of the blocks is 4), Blinding description: In this study, blinding will be done in the type of supplement or placebo for researchers and patients. In this way, the appearance of the capsules will be the same and their packaging will be the same. Coding (codes will be A and B) will be done by someone outside the study. 3 Liver fibrosis. Intervention 1: Intervention group:Nanocurcumin 40 mg Exir Nano Sina (twice a day),The patients will be received 1 capsule of 40 mg of nano curcumin two times daily for 4 months. Intervention 2: Control group: Placebo (twice a day), The patients will be received 1 capsule of an identical-looking placebo two times daily for 4 months (Appearance similarity of both supplement and placebo in terms of shape and color). Yes - There is a plan to make this available What will be shared: Data collected for the primary and secondary outcomes will be shared. When: Access starting 6 months after publication To whom: he data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by for conducting Meta-analysis. Where to obtain: To access the required data, the researchers can contact Dr. Sayyed Saeid Khayyatzadeh: email address: khayyatzadeh@yahoo.com How to obtain: The request will be assessed by the our group, and if all of us agree to the request, the requested data will be emailed. Comments:
public Hadis Gerami
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences - Faculty of Health - Department of Nutrition
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۶۰ +98 35 3149 2228 geramihadis@gmail.com Yazd University of Medical Sciences scientific Sayyed Saeid Khayyatzadeh
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences - Faculty of Health - Department of Nutrition
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۶۰ +98 35 3149 2228 khayyatzadeh@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) patients between 30 and 70 years of age with liver fibrosis F≥2 referring to the liver and digestive consultation and treatment clinic 30 years 70 years Both History of alcohol intake or current intake of alcohol evidence of other forms of chronic and acute liver diseases (such as viral hepatitis B, C etc), biliary disease, known autoimmune hepatitis and hereditary disorders affecting the liver (storage disease of iron, copper etc) current pregnancy or breastfeeding Use of hepatotoxic medication current Lung and kidney disease Drug abuse, history of cancer Treatment with anti-inflammatory, corticosteroids and hormones medication Use of weight loss medication or diets Intolerance or allergy to the supplement Unwillingness to participate in the study New diet Changes in the patient's medications Patients with current warfarin medications Treatment - Drugs Placebo Intervention group:Nanocurcumin 40 mg Exir Nano Sina (twice a day),The patients will be received 1 capsule of 40 mg of nano curcumin two times daily for 4 months. Control group: Placebo (twice a day), The patients will be received 1 capsule of an identical-looking placebo two times daily for 4 months (Appearance similarity of both supplement and placebo in terms of shape and color). Liver fibrosis. Timepoint: Before and 16 weekes after the intervention. Method of measurement: Determining the amount of liver tissue fibrosis by using Elastography (2D Shear Wave Elastography- SWE). Liver steatosis. Timepoint: Before and 16 weekes after the intervention. Method of measurement: Determining the amount of liver tissue steatosis by using Elastography (2D Shear Wave Elastography- SWE). Liver function tests (LDH ،ALT،AST،Albumin ،GGT ،ALP،Bilirubin Total and Bilirubin Direct). Timepoint: Baseline and 16 weeks. Method of measurement: lab kit. Lipid profile (HDL-c, LDL-c, TG, TC). Timepoint: Baseline and 16 weeks. Method of measurement: lab kit. Fasting glucose, serum insulin. Timepoint: Baseline and 16 weeks. Method of measurement: lab kit. Inflammatory factors Hs-CRP and ESR. Timepoint: Baseline and 16 weeks. Method of measurement: lab kit. Anthropometric indicators (weight). Timepoint: Baseline and 16 weeks. Method of measurement: Weight of a person with light clothes and without shoes (Kg). Anthropometric indicators (waist circumference). Timepoint: Baseline and 16 weeks. Method of measurement: Waist size in the distance between the hip bone and the last rib (cm). Anthropometric indices (body mass index). Timepoint: Baseline and 16 weeks. Method of measurement: The ratio of weight (in kilograms) to the square of height (in meters). Anthropometric indicators (fat mass and fat-free mass). Timepoint: Baseline and 16 weeks. Method of measurement: Using the body composition device. Blood pressure. Timepoint: Baseline and 16 weeks. Method of measurement: Measurement of systolic and diastolic blood pressure (mm Hg). Yazd University of Medical Sciences Approved 2023-01-29 Ethics committee of Shahid Sadoughi University of Medical Sciences, Yazd Yazd - Alam Square - Shahid Sadougi University of Medical Sciences Yazd Yazd Iran (Islamic Republic of)