Comparing the effectiveness of the combination of atorvastatin and aspirin with atorvastatin alone on the severity of liver fibrosis in cirrhotic patients referred to Ali Bin Abi Taleb Hospital in2023-2025
Comparison of the effectiveness of the combination of atorvastatin and aspirin with atorvastatin alone on the severity of liver fibrosis in cirrhotic patients
Design
The trial with two parallel groups, randomized, phase 4, on 81 patients, is done for randomization from the table of random numbers to the form of information in a separate envelope.
Settings and conduct
The trial will be conducted in Ali Bin Abi Taleb Hospital. Liver cirrhosis patients who come to the clinic and meet the conditions to be included in the study will be treated by a gastroenterology specialist, a questionnaire will be filled out, and they will be visited after three months.
Blinding is done by placing information in numbered envelopes
Participants/Inclusion and exclusion criteria
Patients with liver cirrhosis who were diagnosed with manifestations, age 18-75, sonography based on cirrhosis.
Intervention groups
Intervention group 1: atorvastatin and aspirin. Intervention group 2: atorvastatin alone.
Main outcome variables
Quality of life; creatine kinase; liver enzymes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231002059591N1
Registration date:2023-11-03, 1402/08/12
Registration timing:prospective
Last update:2023-11-03, 1402/08/12
Update count:0
Registration date
2023-11-03, 1402/08/12
Registrant information
Name
Bahareh Mahjoubi asil
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5634
Email address
b.mahjoubi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of the combination of atorvastatin and aspirin with atorvastatin alone on the severity of liver fibrosis in cirrhotic patients referred to Ali Bin Abi Taleb Hospital in2023-2025
Public title
Investigating the effect of atorvastatin and aspirin on liver cirrhosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Patients with liver cirrhosis who were diagnosed with symptoms
Age 18-75
Ultrasound based on cirrhosis
Exclusion criteria:
pregnant woman
Statin use in the last year
affected hcc
LDL >70
Myopathy caused by atherostatin treatment
meld>23
child pugh>13
Evidence of infection in the last 4 weeks
Hepatornal syndrome in clinical and biochemical evidence in the last 14 days
High hepatic encephalopathy 2
3 times increase of aminotransferase in 3 months after starting the study
Recent use of febrate, varithromycin and others
useP450 inhibitor
Esophageal varices
Patient dissatisfaction
Age
From 18 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
Investigator
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Block of four will be used for each of the treatment groups. In this way, someone other than the doctor will determine the treatment block with the help of random numbers obtained from the computer.
block therapy:
AABC-ABBC-BBAC-BCCA-.........
A; The group taking atorvastatin
B: The group that takes atorvastatin and copper aspirin
C: The group that does not take medicine
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding: on the one hand, the researcher is not aware of the type of intervention performed, and on the other hand, the doctor evaluating the outcome of the study is also aware of the type of treatment used.
*Allocation concealment is done using "opaque sealed envelopes with random sequence". In this way, the random sequence is determined first, then the sequences are recorded on a card and the cards are placed in the envelopes in order. The outer surface of the envelopes is numbered and placed in the box in order. Participants will choose an envelope in order of entry and the intervention group will be determined
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan Medical Sciences
Street address
Hasabi Square - Imam Hossein Blvd - Zahedan Faculty of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2023-08-20, 1402/05/29
Ethics committee reference number
IR.ZAUMS.REC.1402.260
Health conditions studied
1
Description of health condition studied
Toxic liver disease with fibrosis and cirrhosis of liver
ICD-10 code
K71.7
ICD-10 code description
Toxic liver disease with fibrosis and cirrhosis of liver
Primary outcomes
1
Description
CK: One of the body's muscle enzymes
Timepoint
Every three months to a year
Method of measurement
Measurements from the patient's blood sample
2
Description
AST :SGOT is an enzyme from the group of transferases. In fact, it is a PLP-dependent transaminase that is mainly found in the liver
Timepoint
Every three months to a year
Method of measurement
Measurements from the patient's blood sample
3
Description
It is an enzyme found mainly in the liver, but small amounts are also found in the kidneys, heart, muscles, and pancreas. (SGPT)
Timepoint
Every three months to a year
Method of measurement
Measurements from the patient's blood sample
4
Description
PT:Blood clotting time
Timepoint
Every three months to a year
Method of measurement
Measurements from the patient's blood sample
5
Description
PLT:The number of platelets in the serum
Timepoint
Every three months to a year
Method of measurement
Measurements from the patient's blood sample
Secondary outcomes
1
Description
Fib_4 index:Fibrosis index base on index-Non-invasive indicator of liver fibrosis
Timepoint
Every three months to a year
Method of measurement
It is calculated based on age and platelets and AST in the formula
2
Description
Non-invasive indicator of liver fibrosis-Ast to platlet retio index
Timepoint
Every three months to a year
Method of measurement
It is calculated based on AST and PLT in the formula
Intervention groups
1
Description
Intervention group: patients who are given atorvastatin 40 mg and aspirin 80 mg once a day for one year.
Category
Treatment - Drugs
2
Description
Intervention group: patients who were given only atorvastatin 40 mg once a day for one year
Category
Treatment - Drugs
3
Description
Control group: Patients who do not receive any medication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Bin Abi Talib Hospital
Full name of responsible person
Bahareh Mmahjoubi Asil
Street address
Persian Gulf Square - Shahid Mir Boulevard - Ali Bin Abi Talib Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5574
Email
info@sbmu.ac.ir
Web page address
https://alihos.zaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Bahareh Mahjoubi Asil
Street address
Hasabi Square - University Blvd - Islamic Azad University - Zahra Dormitory
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167743545
Phone
+98 54 3341 9431
Email
baharhmahjoubi@gmil.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
1
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Bahareh Mahjoubi Asil
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Hasabi Square - University Blvd - Islamic Azad University - Zahra Dormitory
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Phone
+98 54 3341 9431
Email
baharehmahjoubi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Bahareh Mahjoubi Asil
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Hasabi Square - University Blvd - Islamic Azad University - Al Zahr Dormitory