Evaluating the therapeutic effect of ursodeoxycholic acid on the reduction of serum bilirubin in neonates with prolonged jaundice

Evaluating the therapeutic effect of ursodeoxycholic acid on the reduction of serum bilirubin in neonates with prolonged jaundice: A randomized controlled clinical trial study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180228038895N2

Enrollment

Registered

2023-06-24

Start date

2023-05-31

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Neonatal jaundice. Neonatal jaundice from other and unspecified causes

Interventions

Intervention 1: Intervention group: Administration of ursodeoxycholic acid capsules with a dose of 10 mg per kilogram of baby's weight daily in two divided doses to the intervention group for 5 days d

Eligibility

Sex/Gender

All

Age

14 Days to 28 Days

Inclusion criteria

Inclusion criteria: Serum bilirubin above 10 mg/dl Indirect hyperbilirubinemia (below 1)

Exclusion criteria

Exclusion criteria: Conjugated hyperbilirubinemia (direct bilirubin above 1) Disruption of TSH and T4 Clinical evidence of infection Urinary tract infection Sick neonates

Design outcomes

Primary

Measure	Time frame
Total and direct serum bilirubin. Timepoint: On the day of visit and 5 days after the intervention. Method of measurement: Measurement of serum bilirubin level in serum sample in laboratory with kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Azadeh Hosseini Nouri

Rasht University of Medical Sciences

Dr.azadehoseini@gums.ac.ir+98 13 3336 9026

Outcome results

None listed

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