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effects of Silymarin in the Prevention of hyperbilirubinemia

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231120060123N1
Enrollment
120
Registered
2023-11-21
Start date
2023-12-22
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal jaundice, unspecified. Neonatal jaundice, unspecified

Interventions

Intervention group: In the intervention group, newborns receive oral silymarin drops from the first day of birth at a dose of 4 mg per kilogram of body weight every 12 hours. The silymarin, with a con

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 10 Days

Inclusion criteria

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

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 hospitalizationwith 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 or mothers who have received phenobarbital. Newborns who experience severe drug reactions following the use of silymarin. Parents' refusal to continue treatment.

Design outcomes

Primary

MeasureTime frame
Transcutaneous bilirubin level. Timepoint: 24,48 and 72 hours after birth. Method of measurement: Bilichek device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Goldouzi

Mashhad University of Medical Sciences

GoldouziHR4011@mums.ac.ir+98 51 3801 2502

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026