Comparison of the effect of Anaheal and oral corticosteroids in reducing edema and ecchymosis after rhinoplasty
Design
A randomized, blinded, clinical trial with tow parallel group design of 120 patient.
Settings and conduct
this study is performed in the offices and clinics of kermanshah dental school. 120 rhinoplasty applicants were randomly divided into two groups. In one group, Anaheal 500 is given daily, and in the second group, oral corticosteroids are given daily. the degree of ecchymosis and edema is calculated on a 4-point scale on the third, fifth, seventh days after surgery. the data is then analyzed.
blinding is done with exactly the same drug packages that have secret codes related to the drug. patients and the executor of the project go blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All clients requesting rhinoplasty surgery
exclusion criteria:
Underlying diseases
Taking oral or injectable drugs from other medical centers
History of allergy to corticosteroid
Intervention groups
In almost all patient with Rhinoplasty, edema and ecchymosis are seen as two expected outcomes of rhinoplasty. ecchymosis after surgery can be mild or severe, which depends on several factors, including the type and method of surgery and the patient's tendency to bruise.
Postoperative edema is caused by an increase in interstitial fluid at the sit and can caused pain and, is severe, affect the final outcome of the surgery.
Steroids reduce the permeability of the arteries and prevent exudate and blood from leaving the arteries. In this way, it prevents edema and ecchymosis.
Anaheal is a combination of pineapple stem- derived protease enzymes that is used as an antiedema and antithrombotic and fibrinolytic properties.
Main outcome variables
primary consequence: The rate of edema and ecchymosis
secondary consequence: does not have
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210805052086N1
Registration date:2021-11-04, 1400/08/13
Registration timing:registered_while_recruiting
Last update:2021-11-04, 1400/08/13
Update count:0
Registration date
2021-11-04, 1400/08/13
Registrant information
Name
Yavar Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4652 3190
Email address
yavarsayadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of Anaheal and oral Corticosteroids in reducing Edema and Ecchymosis after Rhinoplasty.
Public title
Comparative study of the effect of Anaheal and oral Corticosteroids in reducing Edema and Ecchymosis after Rhinoplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All clients requesting rhinoplasty surgery
Exclusion criteria:
Underlying diseases such as hemophilia, asthma, and liver and kidney failure
Taking oral or injectable drugs from other medical centers
History of allergy to corticosteroid
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The samples studied in this study will be done using random assignment of patient to the study groups. In the study, samples are assigned to the two groups by permutation block random sampling. Thus, the study will continue until the number of samples is completed.
In the method, we first determine a sample size of the general sample and then randomly assign a set of them to one group and the rest to another group. to the perform this randomization method, we proceed as follow:
1- The total sample size and the sample size ratio in the groups are determined. in the study, the number of samples will be 120 people with a 1:1 allocation.
2- The number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9.
3- For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block of 0.5. block 0-4 can be used for the first group and block 5-9 for the second treatment.
4- Based on the selected numbers from the table of random numbers and determination of blocks, it is clear in which group each person who enters the study will be placed
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are treated with medication packages pre-determined by the study supervisor. drug packages are a quite similar in shape and patients are not aware of the contents of the packages. The cards with the number 1 and 2 on them and the secret codes related to the drug are in the packages and every patient who enters the study and receives the medicine dies not know the type of medicine. In addition, collecting information, assessing patients and completing forms is done by the project manager and his assistant, who are not aware of the contents of the packages; Therefore, the study is double-blind and the contents of the two drug groups are not clear from the stage of the patient entering the study until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Boulevard, Building No. 2 of Medical Sciences, Research and Technology Department
City
Kermanshah
Province
Kermanshah
Postal code
671463159
Approval date
2021-10-19, 1400/07/27
Ethics committee reference number
IR.KUMS.REC.1400.531
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
Z41
ICD-10 code description
Encounter for procedures for purposes other than remedying health state
Primary outcomes
1
Description
The rate of edema
Timepoint
Third, fifth and seventh day
Method of measurement
4-point scale
2
Description
The rate of ecchymosis
Timepoint
Third, fifth and seventh day
Method of measurement
4-point scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Take Anaheal 500mg oral tablets twice a day; morning and night, for 7 days
Category
Treatment - Drugs
2
Description
Intervention group: Take prednisolone 5 mg oral tablets twice a day; morning and night, for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sajjad Hospital
Full name of responsible person
Farzad Rezai
Street address
Kermanshah, Bahar St., Sajjad Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6717880167
Phone
+98 83 3725 3607
Email
sajadhospital@domain.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Deputy of Research and Technology, Building No.2, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
reseaech_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research and Technology
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farzad Rezai
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shura St.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
Far_rezaei@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yavar Sayadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Unit 1, 10th Floor, E11 Block, Shaghayegh Blvd., Pardis Town
City
Kermanshah
Province
Kermanshah
Postal code
6717880167
Phone
0098 83 6523190
Email
yavarsayadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yavar Sayadi
Position
student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Unit 1, 10th floor, E11 Block, Shaghayegh Blvd., Pardis Town.
City
Kermanshah
Province
Kermanshah
Postal code
6717880167
Phone
0098 83 6523190
Email
yavarsayadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available