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IRCT20210306050598N1 IRCT 2021-05-14 Shahid Beheshti University of Medical Sciences Design, production, and comparison of serum level of Ursodeoxycholic acid Nanoemulsion with its capsule form in infants under 5 years with cholestasis Design, production, and comparison of serum level of Ursodeoxycholic acid Nanoemulsion with its capsule form in infants under 5 years with cholestasis 2021-06-05 anticipated 100 Complete https://irct.ir/trial/54836 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Blocked randomized clinical trial. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group treatments, which keeps the numbers of subjects in each group similar at all times, Blinding description: Participants and researchers are kept blind to the prescribed drug form (capsule or nanoemulsion). For blinding, the researcher in charge of sampling from each group, as well as the researcher in charge of drug analysis of samples, are unaware of how patients are placed in each of the groups, and the samples are coded after taking. Also, to blind the participants, capsule and nanoemulsion samples are given to them as a solution with a similar appearance. Bioequivalence CHOLESTASIS. 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/day, in three divided doses. Intervention 2: Control group: These children will receive the contents of Ursodeoxycholic acid capsules produced in Koshan Pharmed Pharmaceutical Co. at a dose of 15 mg/kg/day, in three divided doses. Yes - There is a plan to make this available What will be shared: The documents of this trial will be published in the form of an article after its completion. When: Access period starts 6 months after the results are published. To whom: Researchers, Pediatric Gastroenterologists, Pharmacists. Conditions: Study design, referring, conferences. Where to obtain: The journal of that article would be to publish, Pajohan database. How to obtain: Searching Clinical trial name in search engines. Comments:
public Dr. Naghi Dara
ِDr. Shariati
Tehran Iran (Islamic Republic of) 15468- 155514 +98 21 2222 7021 drdara49@yahoo.com Shahid Beheshti University of Medical Sciences scientific ِDr. Naghi Dara
Shariati
Tehran Iran (Islamic Republic of) 15468- 155514 +98 21 2222 7021 drdara49@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Infants under 5 years with cholestasis no limit 5 years Both Infants with noncompliant parents about blood sampling. Patients who are older than 5 year Infants with presurgery cholestasis. K71.0 Toxic liver disease with cholestasis Treatment - Drugs Treatment - Drugs 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/day, in three divided doses. Control group: These children will receive the contents of Ursodeoxycholic acid capsules produced in Koshan Pharmed Pharmaceutical Co. at a dose of 15 mg/kg/day, in three divided doses 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. 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. Shahid Beheshti University of Medical Sciences Approved 2021-03-02 Ethics committee of Shahid Beheshti University of Medical Sciences, faculty of Medicine Beside Taleghani Hospital, Arabi Ave, Yaman street, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)