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IRCT20210524051384N7 IRCT 2021-11-23 Rasht University of Medical Sciences Evaluation of a single dose of estradiol valerate on the duration of hospitalization and its consequences in patients with severe burns: A clinical trial Evaluation of a single dose of estradiol valerate on the duration of hospitalization and its consequences in patients with severe burns: A clinical trial 2021-12-22 anticipated 50 Complete https://irct.ir/trial/60134 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, in order to assign patients to intervention and control groups, the restricted randomization approach will be used in the form of block randomization. Blocking is commonly used to balance the number of samples assigned to each of the study groups. This method during sampling causes the sample assigned to each of the study groups to be equal. To prevent the last allocation from being detected in the blocks under consideration, we will consider the size of the blocks to be random with a size of 4 or 6.Various packages in R software will be used to generate random numbers, Blinding description: In this study, the participants (patients) would be blinded by sealed envelopes. It should be noted that each created randomized sequences will be recorded on a card, and the cards will be put inside the envelopes respectively. In order to blind researcher, similar syringes, the same color injection solutions for the control and intervention groups will be used. The analyzer will also be blinded according to coding of envelope and syringes . 2 burn. Intervention 1: Intervention group: Intervention group: Intervention group: Patients receiving estradiol valerate upon arrival after receiving consent, standard treatment and single dose of estradiol valerate (manufactured by Abu Reihan factory, Iran) at a dose of 0.5 ml / kg intramuscularly, none Patients included in the study (both intervention group and control group) will not be deprived of routine treatment of burn patients. Intervention 2: Control group: The control group will receive standard treatment. None of the patients included in the study (both intervention group and control group) will be deprived of routine treatment of burn patients. 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 There is no more information
public Mohammad Reza Mobayen
Namjoo Street
rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific Dr. Mohammad Reza Mobayen
Namjoo Street
rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patient with severe burns (second or higher degree burns with an area of more than 20%) Fill out the informed consent form Acute burns have occurred in less than 24 hours. 18 years 50 years Both Electric burns Inhalation burns People with a history of estrogen-dependent cancer (breast, uterus, ovary) Pregnant and lactating people taking phenobarbital, carbamazepine, ritonavir, rifampin, People with a history of thrombophlebitis and thromboembolism. T20 Burn and corrosion of head, face, and neck Treatment - Drugs N/A Intervention group: Intervention group: Intervention group: Patients receiving estradiol valerate upon arrival after receiving consent, standard treatment and single dose of estradiol valerate (manufactured by Abu Reihan factory, Iran) at a dose of 0.5 ml / kg intramuscularly, none Patients included in the study (both intervention group and control group) will not be deprived of routine treatment of burn patients. Control group: The control group will receive standard treatment. None of the patients included in the study (both intervention group and control group) will be deprived of routine treatment of burn patients. Discharge time and speed of recovery. Timepoint: daily. Method of measurement: Based on patients' records. Discharge status. Timepoint: daily. Method of measurement: view of patient file. Duration of hospitalization in the ICU. Timepoint: daily. Method of measurement: patient record. Comparison of changes in inflammatory factor IL-6. Timepoint: on day 1 (before injection of estradiol valerate) and 3 and 7. Method of measurement: ELISA. Itching rate. Timepoint: daily. Method of measurement: based on the patient's statements. Comparison of changes in laboratory indices of serum levels of CRP, ferritin, LDH, CPK. Timepoint: On days 1, 3 and 7. Method of measurement: By laboratory kits. INR, PT, PTT. Timepoint: On days 1, 3 and 7. Method of measurement: By laboratory kits. Serum and blood transfusion. Timepoint: daily. Method of measurement: based on patient records. Rasht University of Medical Sciences Approved 2021-10-27 Research Ethics Committee of Guilan University of Medical Sciences Namjoo St., Velayat Hospital (3rd floor), Clinical Development Center rasht Guilan Iran (Islamic Republic of)