Investigating the effects of Silymarin in the Prevention of hyperbilirubinemia: a randomized, double-blind, placebo-controlled, clinical trial

Determining the effect of oral extract of silymarin in the prevention of neonatal hyperbilirubinemia

A clinical trial with a control and intervention group, parallel-group design, double-blind, randomized, using Random Allocation Software for randomization. The sample size is 120 newborns, with 60 newborns in each group.

The full-term newborns will receive silymarin and placebo drops for 4 days from birth. Bilirubin levels will be measured using TCB for 4 days, and serum bilirubin will be checked as needed, either in the maternity ward or during outpatient NICU visits at Ghaem Hospital for jaundice evaluation.

Inclusion Criteria: Full-term newborns who are negative for the Coombs test at birth, Healthy full-term newborns who do not require phototherapy, Newborns whose bilirubin levels are not in the range requiring blood exchange, Newborns with no history of the mother taking any kind of medication during pregnancy. Exclusion Criteria: Newborns with RH incompatibility who are positive for the Coombs test, Newborns with an increase in bilirubin to the level requiring blood exchange, Newborns requiring phototherapy on the first day of birth, Deterioration in the newborn's condition during hospitalization with dehydration, sepsis, pneumonia, anemia, severe weight loss, hypoglycemia, renal failure, or heart failure, Newborns with a history of the mother taking any kind of medication during pregnancy, Newborns or mothers who have received phenobarbital, Newborns who experience severe drug reactions following the use of silymarin, Parents' refusal to continue treatment.

Healthy full-term newborns from the first day of birth who receive 4 mg per kilogram of weight of oral silymarin drops three times a day for 4 days from birth.

jaundice in the first three days after birth

Randomization method: simple Randomization tool: closed envelope Allocation Concealment: sealed envelopes containing random and equal sequence contents from two intervention and control groups

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

All data can be shared after patients are made unidentifiable.

Data can be accessible 6 months after results are published.

Data will be available for researchers in universities and other scientific institute

After publication as an article, it can be used by the public and researchers of medical universities

Data can be accessible through an email to the corresponding author.

After sending a request email to the corresponding author, data will be sent in 1 month.