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IRCT20210817052218N1 IRCT 2021-12-01 Shahid Beheshti University of Medical Sciences Milk thistle (Silymarin marianum) extract supplementation on nonalcoholic fatty liver disease Effect of milk thistle (Silymarin marianum) extract supplementation on nonalcoholic fatty liver disease in morbidly-obese patient candidates for bariatric surgery 2021-12-16 anticipated 50 Complete https://irct.ir/trial/58206 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients will be based on simple randomization and with the help of accepted methods of random sequence production based on the web. The randomizer.org site will be used by filling in the information on the number of patients, two target groups, assigning an equal number in each group, and selecting non-duplicate numbers in this plan. Based on the random sequence numbers generated at the site, patients will be divided into two groups of 25 people under intervention receiving both lifestyle modification and Silymarin and the placebo group, which will receive the lifestyle modification and a placebo, Blinding description: The allocation will be concealed by using opaque, sealed envelopes that were consecutively numbered. Apart from the project coordinator, the patients, attending physicians, staff involved in the surgery clinics, and members collecting and analyzing data will be blinded to the intervention allocation. 3 Morbid obesity and non alchoholic liver diseade. Intervention 1: Intervention group: 500 kcal.day deficit from their normal weight-maintaining caloric intake plus taking 140 mg of Silymarin in tablet form, four times daily, for a total of 560 mg for eight weeks,. Intervention 2: Control group: 500 kcal.day deficit from their normal weight-maintaining caloric intake plus taking placebo in tablet form, four times daily, for eight weeks,. Yes - There is a plan to make this available What will be shared: Effect of milk thistle (Silymarin marianum) extract supplementation on nonalcoholic fatty liver disease in morbidly-obese patient candidates for bariatric surgery When: in 6 months To whom: Study runners Conditions: coauthorship in data publishing Where to obtain: bariatric surgery teams in iran How to obtain: Sending requests by emails Comments:
public Seyed Hadi Mirhashemi
Bldg SBUM, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 sh.mirhashemi@gmail.com Shahid Beheshti University of Medical Sciences scientific Parviz Rezaee
Bldg SBUM, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 dr.parvizrezaee@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients aged between 18 and 65 years morbidly-obese patients candidates for bariatric surgery , BMI above 40 kg/m2 Diagnosis of NAFLD in liver sonography (grades II and III steatosis) with increased levels of liver enzymes aspartate transaminase (AST) and alanine transaminase (ALT) (above 20 mg/dl for women and 30 mg/dl for men) 18 years 65 years Both history of alcohol consumption diabetes mellitus chronic liver disease use of drugs such as statin, fibrate, non-steroidal anti-inflammatory drugs (NSAIDs), positive results for tests of autoimmune hepatitis and virus markers (hepatitis B surface antigen, hepatitis C virus antibody) unwilling to participate in study E66 Overweight and obesity Treatment - Drugs Placebo Intervention group: 500 kcal.day deficit from their normal weight-maintaining caloric intake plus taking 140 mg of Silymarin in tablet form, four times daily, for a total of 560 mg for eight weeks, Control group: 500 kcal.day deficit from their normal weight-maintaining caloric intake plus taking placebo in tablet form, four times daily, for eight weeks, Aspartate aminotransferase/alanine aminotransferase ratio. Timepoint: before and after two months of treatment. Method of measurement: Blood sample. BMI (body mass index). Timepoint: before and after two months of treatment. Method of measurement: scale. Non alchoholic fatty liver disease. Timepoint: before and after two months of treatment. Method of measurement: Sonography. Liver fibrosis. Timepoint: before and after two months of treatment. Method of measurement: Fibroscan Metavir. Shahid Beheshti University of Medical Sciences Approved 2021-03-06 Ethics committee of Shahid Beheshti University of Medical Sciences, Velenjak Tehran Tehran Iran (Islamic Republic of)