CHOLESTASIS. Toxic liver disease with cholestasis
Conditions
Interventions
Intervention 1: Intervention group: Infants with cholestasis. These children will receive Ursodeoxycholic acid nano emulsion that produced in Shahid Beheshti School of Pharmacy at a dose of 15 mg/kg
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 5 Years
Inclusion criteria
Inclusion criteria: Infants under 5 years with cholestasis
Exclusion criteria
Exclusion criteria: Infants with noncompliant parents about blood sampling. Patients who are older than 5 year Infants with presurgery cholestasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentration of Ursodeoxycholic acid. Timepoint: 0-1-3-5-12 and 24 hr after drug administration. Method of measurement: The blood samples taken from the study group were collected in heparinized tubes and after plasma separation, the plasma was frozen at a temperature of minus 20 ° C and the samples were stored. Samples will analyze by GC-Mass after one day. Calculation of pharmacokinetic factors, Cmax, AUC, Tmax is performed using GC-Mass analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum concentration of Ursodeoxycholic acid. Timepoint: 0-1-3-5-12-24 h after drug administration. Method of measurement: The blood samples taken from the study group were collected in heparinized tubes and after plasma separation, the plasma was frozen at a temperature of minus 20 ° C and the samples were stored. Samples are analyzed by GC-Mass after one day. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Naghi Dara
Shahid Beheshti University of Medical Sciences
Outcome results
None listed