Comparison effect of permethrin shampoo to permethrin shampoo with vinegar in the treatment of head lice in children aged 6-13 years
Design
A clinical trial with a control and intervention group, without blinding, randomized using a table of random numbers, on 110 patients.
Settings and conduct
This study is conducted in the medical centers in the suburbs of Tehran and with patients referred to these centers. After entering, the clients are examined and the patients who are satisfied to participate in the study are divided into two intervention and control groups with a table of random numbers.
The intervention group is treated with "permethrin shampoo and vinegar-soaked comb" and the control group is treated with "permethrin shampoo" for two weeks. At the end of two weeks, the patients are examined again and the results are analyzed statistically.
Participants/Inclusion and exclusion criteria
Conditions for entering the study:
All children aged 3 to 6 who have head lice.
Conditions for not entering the study:
Those who have received anti-insect treatment in the past month.
Children who have an underlying disease.
Children whose parents are not fluent in Persian
Children who do not consent to participate in the study
Children whose parents did not sign the written consent form
Children who are allergic to vinegar or permethrin shampoo.
The family population and the density of people in the patient's house should not be normal
Other family members have symptoms of head lice.
Intervention groups
Intervention group: combined use of permethrin shampoo as a common treatment and comb soaked in vinegar
Main outcome variables
infection with head lice, head lice betterment, Use of permethrin, Using a comb dipped in vinegar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110420006243N5
Registration date:2024-09-18, 1403/06/28
Registration timing:prospective
Last update:2024-09-18, 1403/06/28
Update count:0
Registration date
2024-09-18, 1403/06/28
Registrant information
Name
Shiva Rafati
Name of organization / entity
Shahed university
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9437
Email address
rafati@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of permethrin shampoo to permethrin shampoo with vinegar in the treatment of head lice in children aged 6-13 years
Public title
The effect of vinegar in the treatment of head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children aged 3 to 6 who have head lice
Exclusion criteria:
Those who have received anti-insect treatment in the past month.
Children who have an underlying disease.
Children whose parents are not fluent in Persian
Children who do not consent to participate in the study
Children whose parents did not sign the written consent form
Children who are allergic to vinegar or permethrin shampoo.
The family population and the density of people in the patient's house should not be normal
Other family members have symptoms of head lice.
Age
From 3 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method using the roll of a die method.
For each of the clients whose head lice diagnosis is certain, a dice is thrown separately and in this method, even numbers are assigned to the control group and odd numbers are assigned to the intervention group, and based on this, the clients are divided into two control and intervention groups. they turn
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
First, all the children aged 6 to 13 who have visited the treatment center are examined by trained people, and among them, children with head lice are included in the study after the parents fill in the written informed consent form and the child's basic information questionnaire.Then we divide them into intervention and control groups using a random number table. The people in the two groups should be the same in terms of age, gender, severity of the disease and the number of family members.Then the parents of both groups should be trained about the treatment protocol, intervention protocol and health protocol
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.SHAHED.REC.1402.137
Health conditions studied
1
Description of health condition studied
pediculosis capitis
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis
Primary outcomes
1
Description
infection with head lice
Timepoint
Head examination of children for head lice before the intervention and 14 days after the intervention, using permethrin and vinegar shampoo.
Method of measurement
Examination of children's heads by qualified experts
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Combined use of permethrin shampoo as a common treatment and vinegar-soaked comb
Category
Treatment - Other
2
Description
Control group: Geting permethrin shampoo as a common treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomeini hospital
Full name of responsible person
Amirparsa Khalili
Street address
Italy street
City
Tehran
Province
Tehran
Postal code
1416645151
Phone
+98 21 8899 7163
Email
info@mkht.ir
Web page address
http://mkht.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr.Reza Forouzanfar
Street address
Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Fax
+98 21 5121 5082
Email
publicrelation@shahed.ac.ir
Web page address
https://shahed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
20
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
Shahed University
Full name of responsible person
Amirparsa Khalili
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Italy street
City
Tehran
Province
Tehran
Postal code
1416645153
Phone
+98 21 8899 7230
Fax
+98 21 8896 3739
Email
Amirparsakhalili92@gmail.com
Web page address
http://mkht.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Amirparsa Khalili
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Italy street
City
Tehran
Province
Tehran
Postal code
11416645153
Phone
+98 21 8899 7230
Fax
+98 21 8896 3739
Email
Amirparsakhalili92@gmail.com
Web page address
http://mkht.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Amirparsa Khalili
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Italy street
City
Tehran
Province
Tehran
Postal code
1416645153
Phone
+98 21 8899 7230
Fax
+98 21 8896 3739
Email
Amirparsakhalili92@gmail.com
Web page address
http://mkht.ir/
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 potential data is shareable after de-identifying individuals.
When the data will become available and for how long
Beginning of the information access period: 6 months after the results are published
To whom data/document is available
Researchers working in related academic and scientific institutions
Under which criteria data/document could be used
Those who want to use the data and documents of this study. Must apply via email. After reviewing their request and the reason for their need for information and the approval of the research team, the information will be sent.
From where data/document is obtainable
People should explain the reason for the request, the need for information and the type of analysis they want to do on the data through an email to amirparsakhalili92@gmail.com.
What processes are involved for a request to access data/document
Individuals should explain the reason for the request, the reason for needing the information and the type of analysis they want to perform on the data in an email.
Their request has been reviewed by the research team.
And after the approval of the research team, the information will be sent.