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Efficacy of Ursodeoxycholic acid in the treatment of indirect hyperbilirubinemia in neonates

Investigating the efficacy of Ursodeoxycholic acid on indirect hyperbilirubinemia in neonates treated with phototherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170719035178N2
Enrollment
88
Registered
2019-02-10
Start date
2018-10-12
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

Indirect Hyperbilirubinemia. Neonatal jaundice due to excessive hemolysis, unspecified

Interventions

Intervention 1: Intervention group: Patients in this group are treated by phototherapy and capsules of Urosobil (manufactured by Alborz Pharmaceuticals and dissolved in 10 cc infant milk) at 10 mg/kg

Sponsors

Sabzevar University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 14 Days

Inclusion criteria

Inclusion criteria: Birth weight more than 2500 gr Gestational age more than 37 weeks The birthday more than 2 days and less than two weeks The total bilirubin level is 14-20 mg/dl and the direct bilirubin level is less than 2 mg/dl No Septicemia lack of Crigler–Najjar syndrome lack of Thyroid disease lack of Liver disease lack of direct hyperbilirubinemai Incompatibility of blood groups and RH lack of G6PD deficiency Infants aged 2 to 14 days

Exclusion criteria

Exclusion criteria: Parental dissatisfaction for any reason The incidence of any side effects of Ursodeoxycholic acid Infants from diabetic mother

Design outcomes

Primary

MeasureTime frame
Total bilirubin. Timepoint: The time intervals for measuring total bilirubin levels are at the baseline (before the intervention), 12, 24, and 36 hours after starting treatment (phototherapy with or without Ursobil). Method of measurement: Autoanalyzer devices.

Secondary

MeasureTime frame
Drug side effects. Timepoint: During the intervention at 12, 24, and 36 hours after intervention. Method of measurement: Clinical evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMitrah Aldaghi

Sabzevar University of Medical Sciences

Aldaghim@medsab.ac.ir+98 51 4411 1071

Outcome results

None listed

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