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IRCT20080901001155N31 IRCT 2019-05-17 Rasht University of Medical Sciences The efficacy of Ursudoxicolic acid combination with fenofibrate in patients with primary sclerosing cholangitis Comparative study of the effect of the combined method ursodeoxycholic acid and fenofibrate with single-drug method ursodeoxycholic acid on clinical features and Laboratory tests in primary sclerosing cholangitis. 2019-04-06 anticipated 30 Complete https://irct.ir/trial/38131 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment in this study will be in the form of block Randomization. In this way, the number of people in the two groups A and B is the same throughout the study period, Blinding description: This double-blind study will be conducted. The first part of the blinding is for patients who do not know which drug (A group and B group) they received. The next section is about the person who asked for the medication to be given to patients who are not A or B drug. N/A primary scleroding cholangitis. Intervention 1: Intervention group: UDCA drug dose of 300 mg daily 8 to 10 mg per kilogram of body weight divided into two to three doses by So.Se.Pharm plus fenofibrate dose of 200 mg b.i.d for 12 weeks by Sobhan. Intervention 2: Control group: UDCA drug dose of 300 mg daily 8 to 10 mg per kilogram of body weight divided into two to three doses by So.Se.Pharm plus placebo dose of 200 mg b.i.d for 12 weeks by Sobhan. Yes - There is a plan to make this available What will be shared: The main outcome of this study, which is to treat primary sclerosing cholangitis, reduce clinical signs and laboratory improvements, will be made available to the general public. When: A year after printing results To whom: Researchers at relevant research centers, universities, and related doctors Conditions: In this case, the decision has not yet been taken Where to obtain: Sara yeganeh Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht 00981333535116 955655-41448 Yeganeh_sara6@yahoo.com How to obtain: At the outset, the applicant will email and complete his or her full introduction of the organization and the purpose of obtaining this data and will request the relevant documents or files.Subsequently, the data files will be made available to the applicant within the time period stated by the relevant investigator Comments:
public دکتر فرحناز جوکار
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
Rasht Iran (Islamic Republic of) 41448956655 +98 13 3353 5116 farajov@yahoo.com Rasht University of Medical Sciences scientific دکتر فریبرز منصور قناعی
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
Rasht Iran (Islamic Republic of) 41448956655 +98 13 3353 5116 ghanaie@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with PSC disease confirmed by a specialist using ERCP or MRCP. 20 years 70 years Both 80.5 K80-K87 Treatment - Drugs Placebo Intervention group: UDCA drug dose of 300 mg daily 8 to 10 mg per kilogram of body weight divided into two to three doses by So.Se.Pharm plus fenofibrate dose of 200 mg b.i.d for 12 weeks by Sobhan. Control group: UDCA drug dose of 300 mg daily 8 to 10 mg per kilogram of body weight divided into two to three doses by So.Se.Pharm plus placebo dose of 200 mg b.i.d for 12 weeks by Sobhan. Primary scleroding cholangitis treatment. Timepoint: Before starting treatment, weeks 6, 12,18,24,30,36 from the point of view ALT, AST, ALP, Gamma- Glutamyl transpeptidase, Bilirubin Total, Bilirubin Direct,Albumin and Prothrombin and weeks 12,24,36 from the point of view TG, Total-Cholesetrol and LDL. Method of measurement: Blood test. Response to treatment and possible side effect. Timepoint: Weeks 6, 12,18,24,30,36 from the point of view ALT, AST, ALP,Gamma-Glutamyl transpeptidase,Bilirubin Total,Bilirubin Direct,Albumin and Protrombin and weeks 12,24,36 from the point of view TG, Total-Cholestrol and LDL. Method of measurement: Blood test. Rasht University of Medical Sciences Approved 2019-02-23 Ethics Committee of Guilan University of Medical Sciences. Research and Technology Deputy ,Shaheed Beheshti street,Gaz square Rasht Guilan Iran (Islamic Republic of)