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IRCT20200523047549N2 IRCT 2022-05-11 Shahid Beheshti University of Medical Sciences : Evaluation of the effectiveness of plantago ovata on ecchymosis and edema afterrhinoplasty : Evaluation of the effectiveness of plantago ovata on ecchymosis and edema after open rhinoplasty 2022-05-22 anticipated 33 Complete https://irct.ir/trial/63294 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random chain construction of two groups of 33A (intervention group) and B (control group) using Excel software will be used. In a column of 33 letters A and 33letters B and in the adjacent column with the Rand command, make 66 random numbers. Arrange both columns in random order from large to small. The sequence of letters A and B will be the random sequence used, Blinding description: Patients are unaware of receiving ointment containing medication and placebo. Because the ointment containing the gel and the placebo are both given to patients in the same package, the doctor is also unaware of which side the patients used the medicine for. Therefore, the study will be two-way blind. 3 Echymosis and Edema. Intervention 1: Intervention group: The intervention group includes one side of the nose in patients who have undergone open rhinoplasty surgery and after surgery will receive asparagus seeds as a gel containing asparagus seeds prepared with the cooperation and approval of the International School of Pharmacy, Shahid Beheshti University. will be. Intervention 2: Control group: The control group on the opposite side of the nose will be in the same patients who have undergone open rhinoplasty surgery and after surgery will receive the same placebo gel, which is similar to the gel containing pomegranate seeds but has no properties. Yes - There is a plan to make this available What will be shared: Study results, data and statistical codes will be published through reports and articles. When: Access period 6 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Access to the data with the permission of the person in charge of the study is allowed only for scientific research. Where to obtain: Correspondence with the researcher via email How to obtain: Request from the study researcher, one month after the request. Comments:
public Feizollah Niazi
Yadegar Imam Highway, Saadat Abad Intersection, Tehran Province
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 feizollahniazi2015@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Feazollah Niazi
Yadegar Imam Highway Saadat Abad Intersection, Tehran
Tehran Iran (Islamic Republic of) 3438319987 +98 21 2207 4087 feazollahniazi2015@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All candidates for rhinoplasty Informed consent to participate in the study no limit no limit Both Pregnancy of patients Heart and lung diseases People with a history of previous rhinoplasty Use of other local or oral medications for edema and ecchymosis 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 one side of the nose in patients who have undergone open rhinoplasty surgery and after surgery will receive asparagus seeds as a gel containing asparagus seeds prepared with the cooperation and approval of the International School of Pharmacy, Shahid Beheshti University. will be. Control group: The control group on the opposite side of the nose will be in the same patients who have undergone open rhinoplasty surgery and after surgery will receive the same placebo gel, which is similar to the gel containing pomegranate seeds but has no properties. Severity of edema. Timepoint: 8 hours after surgery, 16 hours after surgery, 24 hours and 48 hours after rhinoplasty. Method of measurement: Physical and clinical evaluation based on Pitting Edema criteria. Severity of ecchymosis. Timepoint: 8 hours after surgery, 16 hours after surgery, 24 hours and 48 hours after rhinoplasty. Method of measurement: Physical and clinical evaluation. Shahid Beheshti University of Medical Sciences Approved 2022-03-08 Research Ethics Committees of School of Medicine Shahid Beheshti University of Medical Sciences Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)