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IRCT20211205053287N1 IRCT 2022-04-28 Shahre-kord University of Medical Sciences Evaluation the efficiency of coenzyme Q10 (ubiquinone) supplementation on cisplatin-induced nephrotoxicity Evaluation the efficiency of coenzyme Q10 (ubiquinone) supplementation on cisplatin-induced nephrotoxicity inpatients under chemotherapy 2022-04-21 anticipated 46 Complete https://irct.ir/trial/62250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomized using random allocation software. In the software, the number of groups and the number of samples and the type of groups are determined. Then the numbers 1 to 46 are randomly assigned to the control group and the intervention group. Intervention group: A Control group: B, Blinding description: In order for the patient and the intervening physician to remain blind in the intervention, all maltodextrin capsules are separated from the blister and the placebo is prepared in a series of pre-prepared medicine containers completely similar to the original drug form by the executor. The intervening physician and patients are kept blind to the type of drug (main or placebo) and the type of grouping A and B (which is the main group and which group is placebo). 3 Nephrotoxicity due to cisplatin. Intervention 1: Intervention group: In 23 patients receiving cisplatin after checking the conditions for inclusion in the study, BUN, cr, GFR, Blood Group, Rh tests were checked and 60 Q10 tablets (produced by the drug treatment company) were given to them. Each tablet contains 30 mg of Q10 supplement and should be taken daily for 2 months. After the pills are completed, the patients' kidney function tests are checked again. Intervention 2: Control group: 23 patients receiving cisplatin who will receive a placebo capsule containing 20 g of maltodextrin daily (produced by Amin Isfahan Pharmaceutical Company) for two months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Dr.Mehrdad Sepehrnia
Kashan, Ayatollah Kashani St., Mullah Abdul Razzaq St., Kashi, in front of Ketabchi Conservatory, 13 Alley, Velayat, No. 24
kashan Iran (Islamic Republic of) 8714654738 +98 31 5549 2237 dr.sepehrnia2008@yahoo.com Shahre-kord University of Medical Sciences scientific Dr.Mehrdad Sepehrnia
Kashan, Ayatollah Kashani St., Mullah Abdul Razzaq St., Kashi, in front of Ketabchi Conservatory, 13 Alley, Velayat, No. 24
Kashan Iran (Islamic Republic of) 8714654738 +98 31 5549 2237 dr.sepehrnia2008@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 1- Age between 80-20 years, 2- Do not take antioxidant and anti-inflammatory supplements for at least 1 month before the start of the study 3- Willingness to cooperate in the research project and completing the informed consent form Community Verified icon 20 years 80 years Both 1- Changing the method of drug treatment and taking antioxidant and anti-inflammatory supplements during the study period 2- Changing lifestyle (changing diet, physical activity and level of mental stress) during the study N14.1 Nephropathy induced by other drugs, medicaments and biological substances Prevention Placebo Intervention group: In 23 patients receiving cisplatin after checking the conditions for inclusion in the study, BUN, cr, GFR, Blood Group, Rh tests were checked and 60 Q10 tablets (produced by the drug treatment company) were given to them. Each tablet contains 30 mg of Q10 supplement and should be taken daily for 2 months. After the pills are completed, the patients' kidney function tests are checked again. Control group: 23 patients receiving cisplatin who will receive a placebo capsule containing 20 g of maltodextrin daily (produced by Amin Isfahan Pharmaceutical Company) for two months. Nephrotoxicity due to cisplatin. Timepoint: In patients receiving cisplatin, the tests are checked once before starting (Q10) supplementation and once after supplementation (2 months later). Method of measurement: Check blood urea nitrogen (BUN) and creatinine (Cr) for patients. Shahrekord University of Medical Sciences Approved 2021-09-28 Ethics committee of Shahrekord University of Medical Sciences Chaharmahal and Bakhtiari - Shahrekord city - Kashani boulevard - Parstar street - Hajar hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)