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IRCT20190911044744N1 IRCT 2019-09-22 Shiraz University of Medical Sciences The effect of silymarin on serum liver enzyme level in patients with trauma Comparison of the effect of silymarin and placebo on serum liver enzyme level in patients with trauma in the Intensive Care Unit in Rajaei hospital 2019-10-11 anticipated 90 Complete https://irct.ir/trial/42117 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: Permuted block randomization. The patients are divided into 18-person groups. Using the statistical software, 9 out of 18 patients are randomly assigned to treatment group and 9 to placebo group. Unit of randomization: Individual. Tools used in randomization: computer software, Blinding description: In this study, the participants, the principle investigator, the physicians and the data collectors are blinded. The patients who are going to receive the drug or placebo , are determined by numbers and these numbers are given to the head nurse and nurses of the ICU. 3 Liver Trauma. Intervention 1: Intervention group: Receiving Livergol tablet 140 mg Goldaru factory orally every eight hours for 14 days yo reduce liver enzyme levels. Intervention 2: Control group: Receiving placebo witch was Prepared in pharmaceutical laboratory of Shiraz School of Pharmacy in similar to livergol tablet in size and color orally every eight hours for 14 days. 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 It is not yet known if there will be a plan to make this available
public Ehsan Mirzaei
Shiraz school of pharmacy, Karafarin Street, Roknabad Town
Shiraz Iran (Islamic Republic of) 713451583 +98 71 3242 4127 ehsan.mirzaei.1369@gmail.com Shiraz University of Medical Sciences scientific Ehsan Mirzaei
Shiraz school of pharmacy, Karafarin Street, Roknabad Town
Shiraz Iran (Islamic Republic of) 713451583 +98 71 3242 4127 ehsan.mirzaei.1369@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) People aged 16 or over Not taking a known hepatotoxic drug Not taking oral silymarin during the past day No confirmed history of allergic reactions following oral administration of silymarin Alanine aminotransferase (ALT) levels more than 2-fold above normal (> 70 IU / L) up to 4-fold above normal Or aspartate aminotransferase (AST) levels more than 2-fold above normal (> 70 IU / L) up to 4-fold above normal Not taking concomitant antioxidants or compounds such as vitamin A, C, E and N-acetyl cysteine Oral tolerance to medications 16 years no limit Both Pregnancy or lactation History of advanced liver disease S36.112 Contusion of liver Treatment - Drugs Treatment - Drugs Intervention group: Receiving Livergol tablet 140 mg Goldaru factory orally every eight hours for 14 days yo reduce liver enzyme levels Control group: Receiving placebo witch was Prepared in pharmaceutical laboratory of Shiraz School of Pharmacy in similar to livergol tablet in size and color orally every eight hours for 14 days Decreased liver enzyme levels. Timepoint: Start of study, end of first week, end of second week. Method of measurement: Blood test. Measurement of free radicals. Timepoint: The beginning and the end of the study. Method of measurement: Blood test. Shiraz University of Medical Sciences Approved 2019-08-23 Ethics committee of Shiraz University of Medical Sciences Shiraz school of pharmacy, Karafarin street, Roknabad Town Shiraz Fars Iran (Islamic Republic of)