General purpose:
Determining the effect of Curcumin on improving the symptoms of patients undergoing rhinoplasty surgery
Design
Clinical trial with control group with parallel and double-blind, randomized phase 3 phase on 110 patients
Random number table was used for randomization
Settings and conduct
After obtaining informed written consent from patients with inclusion criteria in Alzahra hospital 110 patients are selected and included in the study.Patients will then be divided into two equal groups with random allocation software 1.0 . The first group will receive a placebo as a control and the second group will receive curcumin.The drug is started in the form of 500 mg capsules daily for two weeks.For patients in the placebo group, the drug is prepared in the same style and form of the main drug, and the same form of drug is started.For blinding drugs and placebo are placed in special packages and numbers A and B are placed. The person prescribing the drug, the patient and the person analyzing the drug have no information about the type of drug.Data collection tools in this study are Sino-nasal Outcome Test (SNOT-22) scale and NOSE (nasal obstruction septoplasty effectiveness) scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients undergoing rhinoplasty due to dissatisfaction with the shape of the nose
2. No history of allergy to Curcumin
3- Satisfaction to participate in this study
4. No sinusitis
5. No nasal polyps
6. No systemic diseases
7. No MS
8. No cleft lip or palate or both
9- No space-absorbing mass in the nose
Criteria for not entering:
1. Do not use medicine
2. Do not use other anti-inflammatory drugs
Intervention groups
Intervention group of patients who are given Curcumin
Control group of patients who are given placebo
Main outcome variables
SNOT-22 score, NOSE score, Duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200819048463N1
Registration date:2020-11-19, 1399/08/29
Registration timing:registered_while_recruiting
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
Ahmad Rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3223 4622
Email address
dr.ahmadrezaeian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-17, 1399/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Curcumin on the improvement of patients undergoing rhinoplasty
Public title
The effect of Curcumin on the improvement of patients undergoing nose surgury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing rhinoplasty due to dissatisfaction with the shape of the nose
No history of allergy to Curcumin
Satisfaction to participate in this study
No sinusitis
No nasal polyps
No systemic diseases
No MS
No cleft palate or lips or both
Lack of space-absorbing mass in the nose
Exclusion criteria:
Do not use medicine
Do not use other anti-inflammatory drugs
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
110 patients who meet the inclusion criteria are admitted to the study as unlikely and easy, and the treatment is assigned to two groups randomly with the help of web-based randomization. To do this, the website www.grphpad.com is used to generate a random sequence for two-group trials. The unit is an individual randomization. First, the names of all 110 patients are prepared as a list and are numbered from one to one hundred and ten, respectively. In the second step, in the new randomization section of the website, enter the number of people in each sample, which is 55, and then press the button. Web site sequencing equates one to one hundred and ten options A or B equally. Individuals assigned to group A are treated with curcumin and those assigned to group B are treated with medication. They will be placed on the facade
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, researchers, and outcome evaluators and data analysts do not know which group every person belong toIn such a way that an independent person is selected as a random divider of patients and a distributor of drugs among selected patients, the doctor refers each patient to that person and he / she, based on the random list he / she has prepared, gives each patient the medicine that should be in his / her group. To receive
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hzarjerib street
City
Esfahan
Province
Isfehan
Postal code
9987654213
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.MUI.MED.REC.1398.565
Health conditions studied
1
Description of health condition studied
Evaluation of the effect of curcumin on the recovery of patients after rhinoplasty
Before, one week, two weeks and one month after surgery
Method of measurement
NOSE scale
2
Description
Sino nasal outcome test 22 (SNOT22) score
Timepoint
Before, one week, two weeks and one month after surgery
Method of measurement
SNOT22 scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Curcumin reciverFor this group of patients Curcomax capsules should be given, it is considered that this capsule was made by Health Company in England, and each 500 mg capsule contains 400 mg of turmeric extract or root. The patient has been taking one of these oral capsules daily since the day after surgery and has been taking this medicine for a month.
Category
Treatment - Drugs
2
Description
Control group: Placebo receiverFor this group of patients, placebo medicine with the same shape, weight, color and packaging has been prepared by the same company, and each patient uses a 500 mg placebo capsule daily from the first day after surgery and takes this medicine for a long time. Consumes a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Doctor Ahmad Rezaeian
Street address
Sofe street
City
Esfahan
Province
Isfehan
Postal code
9987654449
Phone
+98 31 3792 3456
Email
Alzahra@email.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Fereshte Haghjoo
Street address
Hezarjerb street
City
Esfahan
Province
Isfehan
Postal code
0986578999
Phone
+98 31 3793 4567
Email
esfahanunivercicty@email.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Ahmad rezaeian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Shams abady street, Hzaer town
City
Esfahan
Province
Isfehan
Postal code
4565234566
Phone
+98 31 3436 9336
Email
Dr.Ahmadrezaeian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Rezaeian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Esfahan Town, shamsabady Ave, Hezare building, No 23
City
Esfahan
Province
Isfehan
Postal code
9876556778
Phone
+98 31 3223 4622
Fax
Email
Dr.Ahmadrezaeian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Ahmad Rezaeian
Position
Associate proffessor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Shams abady street,Hezare town
City
Esfahan
Province
Isfehan
Postal code
7654367890
Phone
+98 31 3436 9336
Email
Dr.Ahmadrezaeian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
All data can be published
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
All
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
By referring to the university library, the Taza form is registered and the data is given