to determine the effect of Pistacia Atlantica oil on bruising and swelling after rhinoplasty on the patients who refer to Zahedan cosmetic surgery centers
Design
clinical trial with a control and placebo group, randomized, single-blind, sample size: 60 patients
Settings and conduct
People who go to Dr. Dashti's Otolaryngology clinic for rhinoplasty surgery and undergo rhinoplasty surgery in 1402 will be included in the study according to the entry and exit criteria and after obtaining informed consent. . 60 patients are included in the study. Patients are randomly divided into intervention and control groups.It is recommended to the patients after the surgery twice a day to oil the upper part of the cheek and the bruised areas completely with half a milliliter (10 drops) of oil. The packaging of Pistacia Atlantica oil and paraffin will be exactly the same. Follow-up of patients will be done on the third, fifth and seventh days after the surgery in terms of severity of bruising and swelling
Participants/Inclusion and exclusion criteria
criteria for entering the study: 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 Exclusion criteria: 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
Intervention groups
drug: 10 ml of Pistacia Atlantica oil. Control group: placebo: liquid paraffin. Main outcome variables: severity Swelling, severity of bruising
Main outcome variables
Edema severity ; Ecchymosis severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054880N1
Registration date:2023-09-16, 1402/06/25
Registration timing:registered_while_recruiting
Last update:2023-09-16, 1402/06/25
Update count:0
Registration date
2023-09-16, 1402/06/25
Registrant information
Name
Zahra Sarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 903 428 4838
Email address
rahil19975@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-02, 1402/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Pistacia Atlantica on ecchymosis and edema after rhinoplasty surgery, a randomized clinical trial
Public title
Evaluating the efficacy of Pistacia Atlantica on ecchymosis and edema after rhinoplasty surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
In this research, single blinding method is used. So that the patient will not know the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Medical School - University of Medical Sciences Zahedan
Street address
Zahedan, Dr. Hasabi Square, University of Medical Sciences, Faculty of Medicine
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.ZAUMS.REC.1402.032
Health conditions studied
1
Description of health condition studied
Edema and ecchymosis
ICD-10 code
Y81.3
ICD-10 code description
Surgical instruments, materials and general- and plastic-surgery devices (including sutures) associated with adverse incidents
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Dashti's Otorhinolaryngology Clinic
Full name of responsible person
Gholamali Dashti Khovidaki
Street address
Zahedan, the beginning of Health St., Tawheed Intersection. Aramis doctors building
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 935 102 3969
Email
DRDASHTI502@YAHOO.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Dashti Khoiki
Street address
Zahedan - Shahid Motahari Blvd (Airport) - not reaching Khatam Square, Al Zahra Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 935 102 3969
Email
DRDASHTI502@YAHOO.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hashemi Nesab
Position
Specialist assistant in Iranian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Zahedan - Doctor Hasabi Square - University of Medical Sciences campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 34 3211 0860
Email
hashemifa67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gholamali Dashti Khovidaki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan - Shahid Motahari Blvd (Airport) - not reaching Khatam Square, Al Zahra Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 935 102 3969
Email
DRDASHTI502@YAHOO.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra sarani
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816746557
Phone
+98 992 356 6382
Email
rahil19975@gmail.com.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study results, data and statistical codes through published reports and articles
will be.
When the data will become available and for how long
Access period 6 months after publication of results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to data with the permission of the person in charge of the study, only for scientific research
is allowed
From where data/document is obtainable
Correspondence with the corresponding author via email
What processes are involved for a request to access data/document
Request from the person in charge of the study, one month after the request.