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IRCT20161010030246N3 IRCT 2018-11-21 Shiraz University of Medical Sciences Evaluating the effectiveness of Silymarin on the prevention of gentamicin nephrotoxicity SNG Evaluating the effectiveness of Silymarin on the prevention of gentamicin nephrotoxicity in hospitalized patients at Imam Reza & Vali-Asr hospitals in Birjand 2018-07-23 anticipated 60 Complete https://irct.ir/trial/32636 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Multi-center, random blocking permutations, double-blind, placebo-controlled clinical trials, Blinding description: Researcher does not know the drug that the patient gives,is a placebo or the main drug. On the other hand, the participant (the patient) is not aware of the fact that the drug given to him is the main drug or placebo. 3 Gentamicin-induced renal toxicity in hospitalized patients. Intervention 1: Intervention group: In this group, as long as the gentamicin is prescribed, the tablet of silymarin is prescribed by the Goldaru company (Livergol) at an oral dose of 140 mg three times daily. Intervention 2: Control group: in this group patients with gentamicin will receive placebo 140 mg three times a day orally. 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 There is no data
public Iman Karimzadeh
Shiraz-Roknabad-Karafarin street-Faculty of Pharmacy
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4128 karimzadee@sums.ac.ir Shiraz University of Medical Sciences scientific Iman karimzadeh
Department of clinical pharmacy,Namazi hospital,Namazi Squre
Shiraz Iran (Islamic Republic of) 11351 – 71937 +98 71 3647 4332 karimzadee@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) The patient's hemodynamic stability The desire to participate in the study Gentamicin is given intravenous or intramuscular for at least 1 week at a dose of 5 mg / kg / day or 80-100 mg / TDS No history of confirmed acute kidney injury. No history of confirmed chronic kidney injury. No use of gentamicin by intravenous or muscle in the past 14 days. No history of confirmed allergic reactions following oral administration of silymarin No history of confirmed allergic reactions following oral administration of silymarin Do not receive medications or antioxidant compounds such as vitamin C, vitamin E or vitamin A Do not receive high-renal toxicity medicines at the same time Oral tolerance to medications no limit no limit Both A30-A49 Other bacterial diseases Prevention Prevention Intervention group: In this group, as long as the gentamicin is prescribed, the tablet of silymarin is prescribed by the Goldaru company (Livergol) at an oral dose of 140 mg three times daily. Control group: in this group patients with gentamicin will receive placebo 140 mg three times a day orally. Determination of the efficacy of silymarin in preventing renal toxicity due to gentamicin by measuring the malondialdehyde indicator, evaluation of thiol groups, isoprostane and deoxy guanosine, serum creatinine level, serum urea nitrogen, sodium, potassium and magnesium concentration, and calculating sodium, potassium, Magnesium and urea. Timepoint: Sampling from urine and blood (5 ml) of patients before starting the drug (day zero) and on days 1, 2, 3, 5 and 7, treatment with gentamicin. Method of measurement: Measurement of serum and urine levels of electrolytes, urea and creatinine using an autoanalyzer and Isoprostane and desoxy Guanosine indicator will be performed using ELISA and Zell bio kit. Shiraz University of Medical Sciences Approved 2018-07-04 Ethics committee of Shiraz University of Medical Sciences Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)