]>
IRCT20231002059591N1 IRCT 2023-11-03 Zahedan University of Medical Sciences Investigating the effect of atorvastatin and aspirin on liver cirrhosis 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 2023-12-06 anticipated 81 Complete https://irct.ir/trial/72958 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 4 Toxic liver disease with fibrosis and cirrhosis of liver. Intervention 1: Intervention group: patients who are given atorvastatin 40 mg and aspirin 80 mg once a day for one year. Intervention 2: Intervention group: patients who were given only atorvastatin 40 mg once a day for one year. Intervention 3: Control group: Patients who do not receive any medication. Yes - There is a plan to make this available What will be shared: All data can be published without publishing the identity of the patients When: Access to data is six months after printing the results To whom: Researchers who are in scientific and academic institutions Conditions: If the patient consents Where to obtain: bahareh mahjoubi asil baharehmahjoubi@gmail.com How to obtain: Providing proof of being a researcher in academic and scientific institutions by email to baharehmahjoubi@gmail.com Comments:
public Bahareh Mahjoubi Asil
Hasabi Square - University Blvd - Islamic Azad University - Zahra Dormitory
Zahedan Iran (Islamic Republic of) 9816743545 +98 54 3341 9431 baharehmahjoubi@gmail.com Zahedan University of Medical Sciences scientific Bahareh Mahjoubi Asil
Hasabi Square - University Blvd - Islamic Azad University - Al Zahr Dormitory
Zahedan Iran (Islamic Republic of) 9816743545 +98 54 3341 9431 baharehmahjoubi@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) - Patients with liver cirrhosis who were diagnosed with symptoms Age 18-75 Ultrasound based on cirrhosis 18 years 75 years Both 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 K71.7 Toxic liver disease with fibrosis and cirrhosis of liver Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: patients who are given atorvastatin 40 mg and aspirin 80 mg once a day for one year. Intervention group: patients who were given only atorvastatin 40 mg once a day for one year Control group: Patients who do not receive any medication 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. 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. 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. PT:Blood clotting time. Timepoint: Every three months to a year. Method of measurement: Measurements from the patient's blood sample. 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. 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. 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. Zahedan University of Medical Sciences Approved 2023-08-20 Ethics Committee of Zahedan Medical Sciences Hasabi Square - Imam Hossein Blvd - Zahedan Faculty of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)