Therapeutic effect of oral ursodeoxycholic acid on indirect hyperbilirubinemia in full-term neonates undergoing phototherapy in hospital 17 Shahrivar - a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210201050199N1

Enrollment

106

Registered

2021-04-03

Start date

2021-04-19

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Hyperbilirubinemia. Other disorders of bilirubin metabolism

Interventions

Intervention 1: Intervention group: those who will receive oral Urso with phototherapy (administering Urso orally at a dose of 10 mg/kg in divided doses every 12 hours and at the time of hospitalizati

Eligibility

Sex/Gender

All

Age

3 Days to 7 Days

Inclusion criteria

Inclusion criteria: Parents' complete satisfaction with the presence of children in the study Birth weight 2500 to 4000 grams Exclusive breastfeeding, Gestational age 38 to 41 weeks Age 3 to 7 days Total bilirubin 14 to 20 and direct bilirubin less than 2

Exclusion criteria

Exclusion criteria: ABO and RH incompatibility G6PD enzyme deficiency Direct hyperbilirubinemia Septicemia Diseases leading to hyperbilirubinemia (carpenter Kriegler syndrome, Gilbert syndrome, hyperthyroidism, hypothyroidism, liver disease) Preterm Neonate of mothers with gestational diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Total bilirubin. Timepoint: Every 24 hours. Method of measurement: Autoanalyzer device.	—

Secondary

Measure	Time frame
Indirect bilirubin. Timepoint: Every 24 hours. Method of measurement: Autoanalyzer device.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactManijeh Tabrizi

Rasht University of Medical Sciences

drs.tabrizi@gmail.com+98 13 3336 9002

Outcome results

None listed

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