Evaluation of the effectiveness of plantago ovata on ecchymosis and edema after open rhinoplasty
Design
A split body, double-blind, randomized, phase three clinical trial will be performed on 33 patients after rhinoplasty surgery. Excel software rand function was used for randomization.
Settings and conduct
A split body clinical trial study will be performed on 33 patients after blind bilateral rhinoplasty surgery at Modares Hospital affiliated to Shahid Beheshti University of Medical Sciences. Patients and physicians will be blind to the type of medication they receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria will include: candidates for rhinoplasty surgery and informed consentExclusion criteria will include: pregnancy, heart and lung disease, people with a history of previous rhinoplasty, people with respiratory disease and asthma, and the use of other topical or oral medications for edema and ecchymosis.
Intervention groups
The intervention group includes one side of the nose in patients who have undergone open rhinoplasty surgery and after surgery will receive plantago ovata as a gel containing plantago ovata seeds prepared with the cooperation and approval of the International School of Pharmacy, Shahid Beheshti University. The opposite side of the nose 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.
Main outcome variables
Severity of edema, severity of eczema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200523047549N2
Registration date:2022-05-11, 1401/02/21
Registration timing:prospective
Last update:2022-05-11, 1401/02/21
Update count:0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Feizollah Niazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8956
Email address
feizollahniazi2015@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Evaluation of the effectiveness of plantago ovata on ecchymosis and edema after open rhinoplasty
Public title
: Evaluation of the effectiveness of plantago ovata on ecchymosis and edema afterrhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All candidates for rhinoplasty
Informed consent to participate in the study
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine Shahid Beheshti University of Medical Sciences
Surgical instruments, materials and general- and plastic-surgery devices (including sutures) associated with adverse incidents
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.