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Comparing the safety and efficacy of the Ursodeoxycolic acid (Cholicray) and Ursophar in Patients with fatty liver disease and biliary disorders

Protocol summary

Study aim
Determining the side effects, comparing the safety and efficacy of Cholicray and Ursophar drug
Design
Two arm parallel group trial, double blind, randomized, phase 2 on 70 patient. block randomization method will be used.
Settings and conduct
This study will be conducted in Baqiyatallah Hospital in Tehran. Patients will take Cholicray or Ursophar medicine for three months, and the variables of the study will be measured before the beginning and after the end. Patients and caregivers will be unaware of their placement in the intervention or control group
Participants/Inclusion and exclusion criteria
inclusion criteria: Age above 18 years, consent to participate in the study, Presence of liver or biliary disorders such as fatty liver, cholangitis, Primary biliary cirrhosis, Calculus of bile duct. exclusion criteria: pregnancy
Intervention groups
The study has two groups in which, the intervention group will use Ursodeoxycolic acid (Cholicray)( 13to15 milligram per kilogram per day/ Reyhaneh Pharmaceutical Company ) drug and in the control group patients will take Ursophar drugs ( 13to15 milligram per kilogram per day/ Koushan Pharmed pharmaceutical company) within 3 months.
Main outcome variables
AST (aspartate aminotransferase), ALT(alanine transaminase), and ALK.P(Alkaline phosphatase) and possible side effects in these patients such as skin rash, itching, jaundice, nausea, vomiting, vertigo

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210914052480N3
Registration date: 2023-08-05, 1402/05/14
Registration timing: registered_while_recruiting

Last update: 2023-08-05, 1402/05/14
Update count: 0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Alireza Soleymanitabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 4364
Email address
stu.soleymanitabar@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the safety and efficacy of the Ursodeoxycolic acid (Cholicray) and Ursophar in Patients with fatty liver disease and biliary disorders
Public title
Investigation of the safety of Ursodeoxycholic acid (Cholicray)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
above 18 years old Consent to participate in the study Presence of liver or biliary disorders such as fatty liver, cholangitis, Primary biliary cirrhosis, Calculus of bile duct.
Exclusion criteria:
pregnancy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization would be done with 4 units blocks and by Using pre-determined blocks by table of random numbers, we will randomly assign individuals to two groups and prescribe the corresponding medication. Each medication will be assigned a unique code that the therapist will not be aware of, only the researchers will know the order.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants will first learn about the two drugs used in the intervention and control groups. Then they will receive a medicine can with a specific code, so the patient and the clinical caregiver will not know that they are in which one of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah educational and medical center
Street address
Research center; Baqiyatallah University of Medical Sciences, Sheykh-Bahaei intersection, Mollasadra st. Vanak sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-02-27, 1401/12/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.127

Health conditions studied

1

Description of health condition studied
Primary biliary cirrhosis
ICD-10 code
K74.3
ICD-10 code description
Primary biliary cirrhosis

2

Description of health condition studied
Fatty (change of) liver, not elsewhere classified(Nonalcoholic fatty liver disease [NAFLD])
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

3

Description of health condition studied
Calculus of bile duct
ICD-10 code
K80.3
ICD-10 code description
Calculus of bile duct with cholangitis

4

Description of health condition studied
cholangitis
ICD-10 code
K83.0
ICD-10 code description
Cholangitis

Primary outcomes

1

Description
Change in sense of taste
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

2

Description
Alanine transaminase(ALT)
Timepoint
Before the intervention and after the intervention
Method of measurement
Mindray BS-800 Bio-Chemistry Analyzer

3

Description
skin rashes
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

4

Description
eye dryness
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

5

Description
Chest pain
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

6

Description
muscle pain
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

7

Description
Frequent urination
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

8

Description
Total Bilirubin test
Timepoint
Before the intervention and after the intervention
Method of measurement
Mindray BS-800 Bio-Chemistry Analyzer

9

Description
Alkaline phosphatase(ALP)
Timepoint
Before the intervention and after the intervention
Method of measurement
Mindray BS-800 Bio-Chemistry Analyzer

10

Description
Aspartate transaminase(AST)
Timepoint
Before the intervention and after the intervention
Method of measurement
Mindray BS-800 Bio-Chemistry Analyzer

11

Description
Direct Bilirubin test
Timepoint
Before the intervention and after the intervention
Method of measurement
Mindray BS-800 Bio-Chemistry Analyzer

12

Description
skin itching
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

13

Description
skin dryness
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

14

Description
Skin redness and hives
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

15

Description
Nausea
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

16

Description
Vomiting
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

17

Description
heartburn
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

18

Description
flatulence
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

19

Description
diarrhea
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

20

Description
Cramps
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

21

Description
constipation
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

22

Description
early satiety
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

23

Description
blurred vision
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

24

Description
strabismus
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

25

Description
eye pain
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

26

Description
eye redness
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

27

Description
Kidney pain
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

28

Description
dysuria
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

29

Description
Urine color change
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

30

Description
Dyspnea
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

31

Description
Frequent cough
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

32

Description
sputum
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

33

Description
headache
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

34

Description
vertigo
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

35

Description
dizziness
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

36

Description
sleep disorder
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

37

Description
Pain radiating to the limbs
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

38

Description
hearing problems
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

39

Description
olfactory disorder
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

40

Description
tingling
Timepoint
Before the intervention and after the intervention
Method of measurement
asking the patient and filling the checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group receiving URSODEOXYCHOLIC ACID CAPSULE ORAL with a standard dose (13to15 milligram per kilogram per day) or CHOLICRAY (Rayhaneh Pharmaceutical Company) for 3 months.
Category
Treatment - Drugs

2

Description
Control group: The group receiving Ursophar (Koushan Pharmed pharmaceutical company) with a standard dose (13to15 milligram per kilogram per day) for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mohammad Ali Abyazi
Street address
Gastroenterology Clinic, Baqiyat Allah Hospital, Sheykh-Bahaei intersection, Mollasadra st, Vanak sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
yashar862@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Reyhaneh Pharmaceutical Company
Full name of responsible person
Naghmeh Piroozi
Street address
Second floor, No. 5, Parvaneh St., Jalal Al Ahmad St., Tehran
City
Tehran
Province
Tehran
Postal code
1439915481
Phone
+98 31 3859 7203
Email
info@rayhanehpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reyhaneh Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Heiat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Gastroenterology Clinic, Baqiyat Allah Hospital, Sheykh-Bahaei intersection, Mollasadra st. Vanak Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
mohamad.heiat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Ali Abyazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology Clinic, Baqiyatallah Hospital, Sheykh-Bahaei intersection, Mollasadra st. Vanak sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
yashar862@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Soleymanitabar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Students Research Committee, Baqiyatallah University of Medical Sciences, Sheykh-Bahaei intersection, Mollasadra St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 4364
Fax
Email
stu.soleymanitabar@bmsu.ac.ir

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
Undecided - It is not yet known if there will be 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 data would be sent without any personal information of patients
When the data will become available and for how long
after data gathering
To whom data/document is available
Only people with relevant permissions to use confidential information
Under which criteria data/document could be used
The data can be used for statistical analysis and re-examination
From where data/document is obtainable
Mohamad Heiat Phone no. +98 936 687 6929
What processes are involved for a request to access data/document
After calling or sending an email, the data will be sent if the applicant is valid
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