Evaluation and comparison of the therapeutic effect of 4% Dimethicone lotion with 4% Eucalyptus sp essential oil on reducing head lice infection in female primary school students in Kerman.
Evaluation and comparison of the therapeutic effect of 4% Dimethicone lotion with 4% Eucalyptus sp essential oil on reducing head lice infection.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3, on 192 students with head lice, R software is used for randomization.
Settings and conduct
randomly selected 20 girls' elementary schools in Kerman city .
96 female students 4% Dimethicone lotion and 96 other students 4% eucalyptus essence lotion for intervention. During days 1, 7, 14, 21, people are examined to check the effect of drugs.
This study is double-blind, the patient and the researcher are not aware of the type of treatment. The lotions are coded by the pharmacist, and then the drug codes are returned after the results are determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least 20 active eggs; females; age 6-12 years; availability during the research.
Exclusion criteria: Use of other drugs; Using hair color, hair gel, Henna, and vegetable oils; sensitive to essential oils; no access to them.
Intervention groups
Intervention group 1: 4% Dimethicone lotion.
Intervention group 2: 4% eucalyptus escence lotion.
Main outcome variables
Percentage of contamination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211211053349N2
Registration date:2022-09-07, 1401/06/16
Registration timing:prospective
Last update:2022-09-07, 1401/06/16
Update count:0
Registration date
2022-09-07, 1401/06/16
Registrant information
Name
Leila ShiraniBidabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5053
Email address
lshiranibidabadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the therapeutic effect of 4% Dimethicone lotion with 4% Eucalyptus sp essential oil on reducing head lice infection in female primary school students in Kerman.
Public title
Therapeutic effect of 4% Dimethicone lotion with 4% Eucalyptus sp essential oil on reducing head lice infection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female students with head lice
َAged between 6-12 years
Having at least 20 active eggs on visual inspection
Exclusion criteria:
Using hair color, hair gel; Henna, and vegetable oils
Having sensitivity to essential oils
Use of other drugs
People who have already used other treatment methods.
No access to individual
Age
From 6 years old to 12 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
192 female students with head lice lesions participating in the study are randomly assigned to one of two treatment groups. In this study, the block randomization method, blocks of four, is used. Within each block of 4, 2 people are randomly assigned to group A, and two people to group B. 48 blocks of 4 are used to conduct this study. The software used for block allocation is R software. We randomly select created blocks from numbers 1 to 6. Using R software, we choose a random number between numbers 1 and 6. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order. Finally, group A will receive control intervention and group B will receive treatment intervention. Since the study is complete, the data about intervention in each group can be added to the data frame for analysis. The plotblockrand function is used to generate randomization cards to be used when assigning subjects to treatment. Cards are printed and sealed in envelopes, then when a new subject is registered, the next envelope is opened, and the subject is assigned to the appropriate treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind, the patient and the treating doctor are not aware of the type of treatment. Dimethicone lotion 4% and eucalyptus essential oil 4% are coded by the pharmacist and then the drug codes are returned after the results are determined.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Postal code: 7616913555 Phone: 034-31325700
City
Kerman
Province
Kerman
Postal code
Postal code: 7616913
Approval date
2022-07-31, 1401/05/09
Ethics committee reference number
IR.KMU.REC.1401.194
Health conditions studied
1
Description of health condition studied
Head lice
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis
Primary outcomes
1
Description
The percentage of contamination
Timepoint
days1,7,14,28
Method of measurement
Examine
Secondary outcomes
1
Description
Drug resistance
Timepoint
Before starting the intervention, 7, 14 and 21 days after using the lotion
Method of measurement
Counting adult lice and their eggs
Intervention groups
1
Description
The first intervention group, Dimethicone lotion 4%, the amount of Dimethicone lotion used for each person is 50 ml, the contact time of the lotion with the hair is 8 to 10 hours for Dimethicone lotion, both intervention groups after 1, 7, 14 and 21 days later The use of lotion will be examined in order to check the effect of the drug on reducing and stopping pollution in the school.
Category
Treatment - Drugs
2
Description
Intervention group2: The second intervention group was lotion containing 4% eucalyptus essence, The second intervention procedure is a lotion containing 4% eucalyptus essential oil. The 4% eucalyptus essential oil lotion will be formulated by the pharmacognosy and pharmaceutics groups of the Faculty of Pharmacy in a volume of one liter and will be divided into 50 ml packages, and each package will be placed in opaque containers on both sides. They will be given the label of how to use and the ingredients inside the package. Both intervention groups will be examined after 1, 7, 14 and 21 days after consuming the lotion in order to check the effect of the drug on reducing and stopping pollution in the school.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Education schools
Full name of responsible person
Dr Leila Shirani-Bidabadi
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus, postall code: 7616913555
City
Kerman
Province
Kerman
Postal code
Postal code: 7616913
Phone
+98 34 3132 5700
Email
lshiranibidabadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Leila Shirani-Bidabadi
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus, Postal code: 7616913555
City
Kerman
Province
Kerman
Postal code
Postal code: 7616913
Phone
+98 34 3132 5700
Email
lshiranibidabadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr leila shirani-Bidabadi
Position
Associate professsor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Postal code: 7616913555
City
Kerman
Province
Kerman
Postal code
Postal code: 7616913
Phone
+98 34 3132 5700
Email
lshiranibidabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Leila Shirani-Bidabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Postal code: 7616913555
City
Kerman
Province
Kerman
Postal code
Postal code: 7616913
Phone
+98 34 3132 5700
Email
lshiranibidabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Leila Shirani-Bidabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Postal code: 7616913555
City
Kerman
Province
Kerman
Postal code
Postal code: 7616913
Phone
+98 34 3132 5700
Email
lshiranibidabadi@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data analysis
When the data will become available and for how long
2023
To whom data/document is available
Doctors and researchers working in academic institutions
Under which criteria data/document could be used
Only use data analysis
From where data/document is obtainable
Dr Leila Shirani-Bidabadi
What processes are involved for a request to access data/document