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IRCT20200825048515N29 IRCT 2021-04-06 Esfahan University of Medical Sciences Evaluation of the effect of Livergol in reducing peripheral neuropathies induced by cisplatin Evaluation of the effect of Livergol (silymarin extract) in reducing peripheral neuropathies induced by cisplatin in patients undergoing chemotherapy 2021-04-04 anticipated 60 Complete https://irct.ir/trial/55105 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: In this study, the two drugs Livergol and placebo are prepared by the pharmacist with the same color, smell and shape and placed in coded packages and delivered to the patient, and the same instructions are prescribed to the patient. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. N/A Cancer. Intervention 1: Intervention group: In addition to cisplatin chemotherapy, patients in this group will be treated with Livergol 140 mg tablets 3 times a day for 90 days. Intervention 2: Control group: In addition to cisplatin chemotherapy, patients in this group will receive placebo 3 times a day for 90 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Ali Haji Gholami
Internal Medicine Department, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 ali_hajigholami@yahoo.com Esfahan University of Medical Sciences scientific Ali Haji Gholami
Internal Medicine Department, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 ali_hajigholami@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Newly diagnosed cancer and undergoing chemotherapy with cisplatin Having symptoms of peripheral neuropathy after starting chemotherapy Consent to participate in this study 18 years no limit Both Having multiple myeloma Having previous neurological disorders Having diseases that give rise to peripheral neuropathy (such as diabetes) C80.1 Malignant (primary) neoplasm, unspecified Treatment - Drugs Placebo Intervention group: In addition to cisplatin chemotherapy, patients in this group will be treated with Livergol 140 mg tablets 3 times a day for 90 days. Control group: In addition to cisplatin chemotherapy, patients in this group will receive placebo 3 times a day for 90 days. Chemotherapy induced peripheral neuropathy score. Timepoint: Before and after the intervention. Method of measurement: Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT). Isfahan University of Medical Sciences Approved 2019-06-01 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)