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IRCT20220516054880N1 IRCT 2023-09-16 Zahedan University of Medical Sciences Evaluating the efficacy of Pistacia Atlantica on ecchymosis and edema after rhinoplasty surgery Evaluating the efficacy of Pistacia Atlantica on ecchymosis and edema after rhinoplasty surgery, a randomized clinical trial 2023-08-23 anticipated 60 Complete https://irct.ir/trial/71026 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization The random allocation of patients to two groups is done by the permutation block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2 . assimilation The two groups are matched in terms of age and gender using the permutation block stratified randomization method, Blinding description: In this research, single blinding method is used. So that the patient will not know the type of intervention. 3 Edema and ecchymosis. Intervention 1: Intervention group: The intervention group includes people who have undergone rhinoplasty surgery and after the surgery, a dropper containing 10 ml of corn oil is provided to the patients in the intervention group and it is recommended to the patients twice a day for up to seven days after the surgery. Using half a milliliter (10 drops) of oil, grease the upper part of the cheek and the bruised areas completely with Beneh oil prepared at Danesh Banyan Company approved by Zahedan University of Medical Sciences. Intervention 2: Control group: The control group includes people who have undergone rhinoplasty surgery and receive placebo after surgery. Liquid paraffin will be used as a placebo and it will be the same color as oil by food coloring. Kernel oil and paraffin packaging will be exactly the same. It is recommended that patients apply half a milliliter of placebo twice a day for seven days, prepared in Danesh Banyan company approved by Zahedan University of Medical Sciences. Yes - There is a plan to make this available What will be shared: Study results, data and statistical codes through published reports and articles will be. When: Access period 6 months after publication of results To whom: Researchers working in academic and scientific institutions Conditions: Access to data with the permission of the person in charge of the study, only for scientific research is allowed Where to obtain: Correspondence with the corresponding author via email How to obtain: Request from the person in charge of the study, one month after the request. Comments:
public Fatemeh Sadat Hashemi Nesab
Zahedan - Doctor Hasabi Square - University of Medical Sciences campus
Zahedan Iran (Islamic Republic of) 9816743463 +98 34 3211 0860 hashemifa67@gmail.com Zahedan University of Medical Sciences scientific Gholamali Dashti Khovidaki
Zahedan - Shahid Motahari Blvd (Airport) - not reaching Khatam Square, Al Zahra Hospital
Zahedan Iran (Islamic Republic of) 9816737789 +98 935 102 3969 DRDASHTI502@YAHOO.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) having informed and free consent regarding the objectives of the research, not having underlying diseases such as coagulation disorders, heart and lung diseases, not taking contraceptives and aspirin before the operation no limit no limit Both occurrence of uncontrollable allergic symptoms such as moderate to severe itching, or skin reactions such as skin rashes due to the consumption of caraway oil Y81.3 Surgical instruments, materials and general- and plastic-surgery devices (including sutures) associated with adverse incidents Treatment - Other Placebo Intervention group: The intervention group includes people who have undergone rhinoplasty surgery and after the surgery, a dropper containing 10 ml of corn oil is provided to the patients in the intervention group and it is recommended to the patients twice a day for up to seven days after the surgery. Using half a milliliter (10 drops) of oil, grease the upper part of the cheek and the bruised areas completely with Beneh oil prepared at Danesh Banyan Company approved by Zahedan University of Medical Sciences. Control group: The control group includes people who have undergone rhinoplasty surgery and receive placebo after surgery. Liquid paraffin will be used as a placebo and it will be the same color as oil by food coloring. Kernel oil and paraffin packaging will be exactly the same. It is recommended that patients apply half a milliliter of placebo twice a day for seven days, prepared in Danesh Banyan company approved by Zahedan University of Medical Sciences. Edema severity. Timepoint: The third day after the operation, the fifth day after the operation, the seventh day after the operation. Method of measurement: Physical and clinical assessment. Severity of ecchymosis. Timepoint: The third day after the operation, the fifth day after the operation, the seventh day after the operation. Method of measurement: Physical and clinical assessment. Zahedan University of Medical Sciences Approved 2022-07-24 Research Ethics Committee of Medical School - University of Medical Sciences Zahedan Zahedan, Dr. Hasabi Square, University of Medical Sciences, Faculty of Medicine Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)