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IRCT20201129049534N3 IRCT 2021-06-30 Esfahan University of Medical Sciences "The effects of coenzyme Q10 supplementation on burn patients" Effect of coenzyme Q10 supplementation on inflammatory markers, oxidative stress factors and clinical outcomes in burned patients: a double-blind placebo-controlled randomized clinical trial 2021-06-20 anticipated 60 Complete https://irct.ir/trial/56570 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After sampling in an easy or accessible way, random allocation of samples is done using the blocking method (4 blocks based on age and sex) and individually. This is done using a reputable random number making website: https://www.sealedenvelope.com/simple-randomiser/v1/lists First, we identify one letter for each group, for example, group A) intervention group (group B), control group (and thus two groups named A and B will be formed and each research unit will be given a number according to the sample size of one A list of 60 people will be obtained, which will be placed in each group of 30 people. Using the website and considering the four blocks, a list consisting of the letters A and B will be prepared randomly. Each participant will be assigned to one of the groups, Blinding description: Q10 and placebo capsules are packaged and covered by Golden Life Company. The capsules will be exactly the same in shape, smell, color, size and will be coded A and B by someone other than the researcher. Patients and researchers will not be aware of the capsule type until the end of the study. 3 burns. Intervention 1: Intervention group: 3 capsules of 100 mg of coenzyme Q10 supplement daily (3 times, one capsule of 100 mg each time, immediately after breakfast, lunch and dinner, a total of 300 mg of coenzyme Q10 daily) for 10 days. From Golden Life Trading Company. Intervention 2: Control group: Control group: 3 100 mg placebo capsules daily (containing maltodextrin) (3 times, one 100 mg capsule each time, immediately after breakfast, lunch and dinner, in a daily dose of 300 mg) for 10 days. From Golden Life Trading Company. Yes - There is a plan to make this available What will be shared: Information about the study will be published after the individuals are not identified and the project is completed. When: Access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Bagherniya email: bagherniya@nutr.mui.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided. Comments:
public Mohammad Bagherniya
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3972 3138 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Bagherniya
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 65-18 years Accept informed consent by the patient or his mobile Gastrointestinal tract with normal function Has a burn above 20% Proper fluid recovery in the first 24 hours and hemodynamic stability after 48 hours 18 years 65 years Both • Patients who are hospitalized for less than 48 hours or do not have stable conditions to start oral or tube feeding. • Dissatisfaction of the patient or family. • Patients with cancer undergoing chemotherapy and cisplatin. Patients receiving warfarin. • Pregnancy Severe and progressive septic shock or sepsis Hypovolemic shock in the first 48 hours Patients who are expected to die within one week of admission. • Patients with a history of certain diseases such as congenital and immune disorders, cirrhosis and pancreatitis. T30.0 Burn of unspecified body region, unspecified degree Treatment - Drugs Placebo Intervention group: 3 capsules of 100 mg of coenzyme Q10 supplement daily (3 times, one capsule of 100 mg each time, immediately after breakfast, lunch and dinner, a total of 300 mg of coenzyme Q10 daily) for 10 days. From Golden Life Trading Company Control group: Control group: 3 100 mg placebo capsules daily (containing maltodextrin) (3 times, one 100 mg capsule each time, immediately after breakfast, lunch and dinner, in a daily dose of 300 mg) for 10 days. From Golden Life Trading Company C reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Erythrocyte sedimentation rate (ESR). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Total antioxidant capacity. Timepoint: At baseline and end f the study. Method of measurement: Commercial diagnostic kit. Total oxidative stress. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. White blood cells (WBC). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Body temperature. Timepoint: At baseline and end of the study. Method of measurement: Measurement with a thermometer. High-density lipoprotein (HDL). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Triglycerides. Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Fasting blood sugar (FBS). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Blood urea nitrogen. Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Creatinine. Timepoint: At baseline and end of the study. Method of measurement: ELISA test. 28-day mortality rate. Timepoint: End of the study. Method of measurement: Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up. Duration of hospitalization. Timepoint: End of the study. Method of measurement: Hospital records. Esfahan University of Medical Sciences Approved 2021-06-09 Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan Hezar-jerib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Sciences Isfahan Isfehan Iran (Islamic Republic of)