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IRCT20201123049474N2 IRCT 2021-08-16 Esfahan University of Medical Sciences Evaluation of prophylactic effect of Livergol (Silymarin) on liver function tests in patients with outpatient cancer undergoing chemotherapy Evaluation of prophylactic effect of Livergol (Silymarin) on liver function tests in patients with outpatient cancer undergoing chemotherapy: a randomized controlled clinical trial 2021-08-23 anticipated 105 Complete https://irct.ir/trial/57641 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done by the method of six balanced block randomization in such a way that in each block with different possibilities, there are two cases A, two cases B and two cases C. Each letter represents the study groups. Creating random values ​​to be assigned to blocks is done in spss software. Then, an independent person from the research team encodes 105 envelopes (based on the codes obtained in the above randomization method) and determines the list of codes. The inside of the envelope will be written according to the above new treatment method or standard (conventional) treatment and in the order of eligible patients entering the clinic, patients will be given to give to the oncologist. The treating physician will prescribe and make the necessary recommendations for each patient based on the grouping performed. The researcher is also unaware of which group each patient is in, Blinding description: The secretary introduced the patients to the oncologist using a randomized grouping and the oncologist provided treatments for all groups according to the grouping done.The investigator,in collaboration with the oncologist,supervised the patient's use of the drug. After collecting the laboratory data, the results was analyzed by a statistician specialist with respect to the confidentiality of the grouping. 3 Chemotherapy induced liver injury. Intervention 1: Intervention group: The first treatment group receives two 140 mg silymarin tablets one week before the start of the chemotherapy course and is taken daily for two months after the chemotherapy treatment. Intervention 2: Intervention group: The second treatment group receives two 140 mg silymarin tablets from the start of the chemotherapy course and is taken daily for two months after chemotherapy. Intervention 3: Control group: They receive two placebo tablets daily for two months from the time of chemotherapy. 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 Not completed the study and data collection
public Safoora Sadat Erfanian
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 1991 S.erfanian72@gmail.com Esfahan University of Medical Sciences scientific Dr Houriye Ansari
Department of Social and Family Medicine
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8123 houri_|ansari@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients aged 30 to 60 years Ability to take the drug orally Definitive diagnosis of breast cancer that has chemotherapy indications and has not yet received its chemotherapy drug Liver tests are normal before the intervention Indication of treatment with chemotherapy regimen 30 years 60 years Both pregnant and breastfeeding liver metastasis and liver disease S36.11 Injury of liver Prevention Prevention Placebo Intervention group: The first treatment group receives two 140 mg silymarin tablets one week before the start of the chemotherapy course and is taken daily for two months after the chemotherapy treatment. Intervention group: The second treatment group receives two 140 mg silymarin tablets from the start of the chemotherapy course and is taken daily for two months after chemotherapy. Control group: They receive two placebo tablets daily for two months from the time of chemotherapy Liver function test. Timepoint: Measurement of liver enzymes at the beginning of the study (before the intervention) and 3 and 6 weeks after the start of silymarin. Method of measurement: Lab data. Esfahan University of Medical Sciences Approved 2020-11-29 Ethics committee of Isfahan University of Medical Sciences Ethics committee of Isfahan medical university, Building No. 4, Isfahan medical university, Hezar Jarib Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)