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IRCT20140804018677N11 IRCT 2021-08-09 Shahid Beheshti University of Medical Sciences Effect of liverpower on liver function in fatty liver Assessing the effect of liverpower supplement on liver function in patients with fatty liver comparing to placebo 2021-07-10 anticipated 80 Complete https://irct.ir/trial/57398 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomize the patients. For randomization, we will visit the www.sealedenvelope.com and use randomization tab to make a list considering the number of intervention groups, sample size, block size ( 4 is selected for current study). The prepared list that contains the pattern of patient allocation will be obtained and used. This site is designed in such a way that there is no limit on the number of groups for random allocation. According to the total number of samples required for the study, which is 80 patients (40 patients in the intervention group (A) and 40 patients in the control group (B)), 20 blocks with a volume of four includes two groups A and B will be randomly selected using the software, such as (ABAB) ، (BBAB)، (AABB)، (ABBA)، (BAAB ......( Then 80pockets (40 pockets containing paper containing A and 40 pockets containing B) will be prepared based on sample size. According to a list of blocks, a trained person outside of the research team will be set the row of pockets. After admission of each patient will be given a pocket and assigned to Group A (intervention) or B (control group), and the sample process will be performed sequentially until the end of completion of sample size, Blinding description: It is a double blind study. A third person out of study team (clinic secretary) have the sequence of codes that provide the team with sealed pockets coded as A or B at the time of sampling. The following groups of people involved in the trial: participants, research team including principle investigator, data collectors, and outcome assessors will be blind. After analyzing the data investigators and outcome assessors will be unblinded about A and B group allocation to supplement and placebo. Patients in supplement and placebo groups will receive packages of similar capsules. 3 Fatty liver. Intervention 1: Intervention group: Intervention group: liverpower (500 mg), Ghaem darou company, three times daily for12 weeks. Intervention 2: Control group: Placebo contain maltodextrine, (500 mg), Ghaem darou company, three times daily for12 weeks. Yes - There is a plan to make this available What will be shared: All data would be available to public When: Starting 6 months after publication To whom: To all Conditions: No other critaria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: ُSending email Comments:
public Soodeh Razeghi Jahromi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razeghi Jahromi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619537 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Liver function enzymes higher than normal level Fatty liver diagnosis based on sonography Age>18 years Willing to participate in the study 18 years no limit Both Having known kidney disease Having known heart disease Pregnancy or lactation K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: Intervention group: liverpower (500 mg), Ghaem darou company, three times daily for12 weeks Control group: Placebo contain maltodextrine, (500 mg), Ghaem darou company, three times daily for12 weeks Alanine Aminotransferase (ALT) enzyme. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical kits. Aspartate transaminase (AST) enzyme. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical kits. Alkaline phosphatase (Alk-ph) enzyme. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical kits. Shahid Beheshti University of Medical Sciences Approved 2019-02-17 Ethics committee of research and technology deputy of Shahid Beheshti University of Medical Sciences No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)