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.
Comparison of the Effects of ursodeoxycolic acid and fenofibrate and ursodeoxycolic acid plus placebo on clinical features and Laboratory tests
Design
double-blind randomized clinical trial,control group
Settings and conduct
This study will be carried out in Gastrointestinal and Liver disease research center. The intervention group will be treated with 300 mg ursodeoxycolic acid daily 8 to 10 mg per kg body weight divided into two to three doses and 200 mg fenofibrate b.i.d dose for 12 weeks. Control group will be treated with 300 mg ursodeoxycolic acid daily 8 to 10 mg per kg body weight divided into two to three doses and 200 mg placebo b.i.d dose for 12 weeks.
Participants/Inclusion and exclusion criteria
1-Confirmation of disease by expert physician with ERCP or MERCP
2- Patients with age 20 or more and below 70 years
3-patients with ALP of 400IU/L or over
Exclusion criteria:1- Secondary screlosing cholangitis
2-Severe jaundice( total bilirubin 5 ULN), َAST or ALT 10 ULN or severe renal disorders (creatinine 1.5 ULN or under hemodialysis)
Intervention groups
This study has 2 groups. every 2 groups will be treated with 300 mg ursodeoxycolic acid. The first group will receive ursodeoxycolic acid plus fenofibrate for 12 weeks and will be considered as an intervention group. The second group will receive ursodeoxycolic acid plus placebo for 12 weeks and will be considered as a control group regimen
Main outcome variables
Treatment of patients with primary sclerosing cholangitis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001155N31
Registration date:2019-05-17, 1398/02/27
Registration timing:registered_while_recruiting
Last update:2019-05-17, 1398/02/27
Update count:0
Registration date
2019-05-17, 1398/02/27
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2020-04-05, 1399/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
The efficacy of Ursudoxicolic acid combination with fenofibrate in patients with primary sclerosing cholangitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with PSC disease confirmed by a specialist using ERCP or MRCP.
Exclusion criteria:
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences.
Street address
Research and Technology Deputy ,Shaheed Beheshti street,Gaz square
City
Rasht
Province
Guilan
Postal code
41448956655
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.GUMS.REC.1397.457
Health conditions studied
1
Description of health condition studied
primary scleroding cholangitis
ICD-10 code
80.5
ICD-10 code description
K80-K87
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز تحقیقات بیماریهای گوارش و کبد گیلان
Full name of responsible person
دکتر فرحناز جوکار
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
City
Rasht
Province
Guilan
Postal code
41448956655
Phone
+98 13 3351 9248
Fax
+98 13 3353 4951
Email
farajov@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
دکتر میر سعید عطارچی
Street address
Sadati st, Namjoo st
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3336 2772
Email
msattarchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
دکتر فرحناز جوکار
Position
معاون مرکز تحقیقات بیماریهای گوارش و کبد
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
City
Rasht
Province
Guilan
Postal code
41448956655
Phone
+98 13 3353 5116
Email
farajov@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
دکتر فریبرز منصور قناعی
Position
استاد-فوق تخصص بیماریهای گوارش و کبد
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
City
Rasht
Province
Guilan
Postal code
41448956655
Phone
+98 13 3353 5116
Email
ghanaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Yeganeh
Position
Master of Microbiology
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Sardare Jangal Avenue
City
Rasht
Province
Guilan
Postal code
41448956655
Phone
+98 13 3353 5116
Email
Yeganeh_sara6@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
A year after printing results
To whom data/document is available
Researchers at relevant research centers, universities, and related doctors
Under which criteria data/document could be used
In this case, the decision has not yet been taken
From where data/document is obtainable
Sara yeganeh Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht 00981333535116 955655-41448 Yeganeh_sara6@yahoo.com
What processes are involved for a request to access data/document
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