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IRCT20211122053144N1 IRCT 2022-01-02 Mashhad University of Medical Sciences Investigating the effects of Silymarin in the treatment of neonatal jaundice Investigating the effects of Silymarin in the treatment of idiopathic hyperbilirubinemia:a randomized,double-blind, placebo-controlled, clinical trial 2022-01-10 anticipated 60 Complete https://irct.ir/trial/60152 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple Randomization tool: closed envelope Allocation Concealment: sealed envelopes containing random and equal sequence contents from two intervention and control groups, Blinding description: This is a double-blind study in which the researcher and the patient do not know about the type of drug. Drugs and placebos are exactly the same in shape, color, smell, and glass, and are codenamed A and B. After collecting the data, the codes are opened and the drug and placebo are identified. 3 Neonatal jaundice. Intervention 1: Intervention group: In the intervention group, in addition to phototherapy, neonates receive from the first day of hospitalization at the rate of 4 mg per kg of body weight every 12 hours oral drops of silymarin with a concentration of 4 mg per cc prepared at the Medicinal Plants Research Center of Mashhad University of Medical Sciences. Serum bilirubin levels are measured 6, 12, 24 and 48 hours after the start of treatment. Intervention 2: Control group: In the control group, in addition to phototherapy, infants receive an equal amount of placebo (distilled water) from the first day of hospitalization. Serum bilirubin levels are measured 6, 12, 24 and 48 hours after the start of treatment. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institute Conditions: After publication as an article, it can be used by the public and researchers of medical universities Where to obtain: Data can be accessible through an email to the corresponding author. Email: mohammadzadehrs991@mums.ac.ir How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Sara Mohammadzadeh Rezaei
Neonatal intensive care unit, Ghaem hospital, Dr. Shariati Square, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2502 mohammadzadehrs991@mums.ac.ir Mashhad University of Medical Sciences scientific Gholam Ali Maamouri
Neonatal intensive care unit, Ghaem hospital, Dr. Shariati Square, Ahmadabad St.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2502 maamourigh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Term neonates who have the AAP criteria for the treatment of hyperbilirubinemia with phototherapy Healthy term neonates who have jaundice from the 2nd to the 10th day of birth and need phototherapy 2 days 10 days Both Neonates with bilirubin level in range of blood exchange The neonate or mother has received phenobarbital Neonates with dehydration, sepsis, pneumonia, anemia, severe weight loss, hypoglycemia, renal failure, heart failure, possible hemolytic or inherited hemolytic disease, neonates with conjugated hyperbilirubinemia, neonates with G6PD, ABO or Rh incompatibility Neonates with a history of jaundice medication from two days before P59.9 Neonatal jaundice, unspecified Treatment - Drugs Placebo Intervention group: In the intervention group, in addition to phototherapy, neonates receive from the first day of hospitalization at the rate of 4 mg per kg of body weight every 12 hours oral drops of silymarin with a concentration of 4 mg per cc prepared at the Medicinal Plants Research Center of Mashhad University of Medical Sciences. Serum bilirubin levels are measured 6, 12, 24 and 48 hours after the start of treatment. Control group: In the control group, in addition to phototherapy, infants receive an equal amount of placebo (distilled water) from the first day of hospitalization. Serum bilirubin levels are measured 6, 12, 24 and 48 hours after the start of treatment. Serum bilirubin. Timepoint: 24,48 and 72 hours after starting phototherapy. Method of measurement: bilirubin kit. Mashhad University of Medical Sciences Approved 2021-09-07 Ethics committee of Mashhad University of Medical Sciences Azadi Square, east door of the university campus Mashhad Razavi Khorasan Iran (Islamic Republic of)