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IRCT20110621006852N2 IRCT 2021-02-28 Ghoum University of Medical Sciences The effect of Atorvastatin in combination to Tenofovir in the treatment of Hepatitis B The effect of Atorvastatin in combination to Tenofovir in the treatment of Hepatitis B 2013-04-21 anticipated 43 Complete https://irct.ir/trial/7293 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participating patients did not know which group was preferred and in which group they are in. Only a specialist knew what group each person was. The analyzer also did not have an idea of which group was better or what type of medication was used, and analyzed only two sets of raw data. 2 Liver Disease. Intervention 1: Intervention group: Receiver of tenofuir and atorvastatin. Tenofovir is the standard hepatitis B drug and is a reverse transcriptase nucleotide inhibitor. To maintain ethical standards, patients with hepatitis B are given Tenofovir manufactured by Hetero Healthcare 300 mg twice a day orally and 40 mg of the study drug, atorvastatin, as tablets made by Poursina factory. The duration of treatment with both drugs is 12 months. To detect the amount of virus, PCR tests are performed at times zero, first month, third month, sixth month, ninth month, and finally the twelfth month to measure the number of viruses in the blood and determine the effect of treatment on the number of viruses. Intervention 2: Control group: Tenofovir recipient alone. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Publishing data file of participants will probably not be useful unless a specialist center intends to carefully study and compare it with other data.
public Mohammad Reza Haeri
Shahid Beheshti Hospital Imam Street, Azadegan Square
Qom Iran (Islamic Republic of) 34937157 +98 25 3291 7376 haeri.mr@gmail.com Ghoum University of Medical Sciences scientific Haeri
Shahid Beheshti Hospital, Imam Street, near Azadegan Square
Qom Iran (Islamic Republic of) 37457731551 +98 25 3291 7376 haeri.mr@gmail.com Qom University of Medical Sciences Iran (Islamic Republic of) Patients with active hepatitis B that are candidates for anti-viral therapy Viral load greater than 100,000 per ml patients with elevated ALT no limit no limit Both All patients with severe kidney failure. Patients who use suppressor drugs for immune system. Patients with acquired or congenital immune deficiencies. Patients who have had a history of taking statins or any other antiviral medicines in the last six months. K71.6 Toxic liver disease with hepatitis, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Receiver of tenofuir and atorvastatin. Tenofovir is the standard hepatitis B drug and is a reverse transcriptase nucleotide inhibitor. To maintain ethical standards, patients with hepatitis B are given Tenofovir manufactured by Hetero Healthcare 300 mg twice a day orally and 40 mg of the study drug, atorvastatin, as tablets made by Poursina factory. The duration of treatment with both drugs is 12 months. To detect the amount of virus, PCR tests are performed at times zero, first month, third month, sixth month, ninth month, and finally the twelfth month to measure the number of viruses in the blood and determine the effect of treatment on the number of viruses. Control group: Tenofovir recipient alone Viral load. Timepoint: At the beginning of the trial and then once every three months interval. Method of measurement: realtime PCR. Ghoum University of Medical Sciences Approved 2015-03-08 Ethics Committee of Qom University of Medical sciences Alqadir Bolivard Qom Ghoum Iran (Islamic Republic of)