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Evaluating the efficacy of ursobil in reducing bilirubin

Evaluating the efficacy of ursodesoxy colic acid (ursobil) in reducing total serum bilirubin

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201701313915N18
Enrollment
120
Registered
2017-02-11
Start date
2017-01-20
Completion date
Unknown
Last updated
2018-02-22

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: Internention group A recieve dissolved oral ursobil 10mg/kg in addition to phototherapy. Intervention 2: Intervention group B recieve dissolved oral ursobil 15mg/kg in addition to phot
Treatment - Drugs
Internention group A recieve dissolved oral ursobil 10mg/kg in addition to phototherapy
Intervention group B recieve dissolved oral ursobil 15mg/kg in addition to phototherapy
Control group recieve water plus phototherapy

Sponsors

Research vice chancellor of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Days to 15 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Birth weight more than 2500 grams; gestation age more than 35 weeks; age above 3 days less than 2 weeks; total serum bilirubin 14-20 mg/dl; direct bilirubin less than 2 mg/dl. Exclusion criteria: ABO incompatibility; Rh immunization; G6PDdefficiency; direct hyperbilirubinemia; sepsis; Crigler-Najjar syndrome; thyroid disorders; hepatic diseases; prematurity; infant of diabetic mother .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The rate of bilirubin decrease. Timepoint: 6,12,24 and 48 hours after starting treatment. Method of measurement: Measurment of total serum bilirubin.

Secondary

MeasureTime frame
The duration of hospitalization. Timepoint: From admission til discharge. Method of measurement: The hours and days of admission.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsane Mokhaleg Sani

Tabriz University of Medical Sciences

gharehbaghimm@yahoo.com+98 41352662257

Outcome results

None listed

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