Determining The effect of topical combination of boiled Allium Sativum and Mentha Pulegium on severity of pollution with pediclusis
Design
Clinical trial with control group, randomized, blinded (infection assessor and data analyst will not be aware of therapeutic intervention type)
The sample size is 126 people divided into two groups of 63 according to the Pokak method.
Settings and conduct
First, based on a simple random-selection health database list, based on the list of girls' schools covered, the two schools are randomly selected from each base to be assigned to the dimethicone group and the decoction group of Allium Sativum and Mentha Pulegium. And in these schools, the units of research will be designated as integers until the sample size is reached. If the desired sample size is not reached, the same steps will be taken to select other schools in the base.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with head lice
Exclusion criteria: no willingness to continue cooperation
Intervention groups
How to do it in the intervention group: After washing the head with a regular shampoo and moisturizing the hair, apply the decoction on the scalp and wet hair. Sufficiently rubbed into the hair, and after 10 minutes under water pressure, remove dead lice and egg lice with a toothpick. A week later the same procedure will repeat. How to perform in control group:
After assuring no sensitivity; from the root to the tip of dry hair, 4% dimethicone lotion is impregnated and after 8 hours, wash with ordinary shampoo and pressurized with water toothpaste, dead lice and eggs Separate the lice from the hair, repeat the same procedure to ensure healing a week later.
Main outcome variables
The effects of " boiled Allium Sativum and Mentha Pulegium" and "4% dimethicone lotion" on the severity of head lice infection vary.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043233N1
Registration date:2020-03-13, 1398/12/23
Registration timing:registered_while_recruiting
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Maryam Paricheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 5965
Email address
paricheh.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical combination of boiled Allium Sativum and Mentha Pulegium on severity of pollution with pediclusis
Public title
The effect of topical combination of boiled Allium Sativum and Mentha Pulegium on severity of pollution with pediclusis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with head lice (presence of at least one live lice and live lice (lice eggs) on examination
Absence of another person with lice in the family on examination
Parent's willingness to cooperate in the project
Use separate bedrooms and bedding, towels and a personal shoulder
Exclusion criteria:
Chronic skin disease
Secondary external ear infection
Hypersensitivity to decoction of boiled Allium Sativum and Mentha Pulegium and dimethicone lotion in the pre-intervention test
Family history of heart disease according to parental reports
History of Hemophilia According to Parental Report
A history of asthma, allergies, and skin allergies, according to a parent report
Use Anti-lice over the past 30 days
Age
From 7 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-stage sampling will be performed. First, based on the list of health bases at the city level, a simple random selection will be made. Again, based on the list, girls' schools covered by this database (due to the possibility of intervention and evaluation by the researcher), two schools (due to the possibility of differences in socio-economic conditions of the students of the two schools) by simple random method based on the draw of each The bases are assigned to the dimethicone group and the decoction group of garlic and oregano. And in these schools, the research units will be designated as integers until the sample size is reached. If the target sample size is not reached, the same steps will be repeated for selecting other base schools and, if necessary, selecting another base and schools.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad, Asian Road Margin
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.GMU.REC.1397.12.6
Health conditions studied
1
Description of health condition studied
pollution to pediclusis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The severity of pediculosis infection (lice)
Timepoint
Before intervention,days of and 14 days after intervention
Method of measurement
Magnifying glass with Zoom in x527; Tailor and fine tooth comb
Secondary outcomes
empty
Intervention groups
1
Description
Once the louse infection is confirmed and the assessor determines the severity of the infection, the parent should be instructed on how to use dimethicone lotion: After making sure that the dimethicone lotion is not sensitized(Rub some lotion on the back of the head), you should first Apply 4% dimethicone lotion from the root to the tip of the dry hair (hair should not be wet or damp). Care should be taken that the entire scalp is completely covered with lotion. After 8 hours, you should rinse your hair with regular shampoo and remove the dead lice and egg lice under water pressure with a fine tooth comb. To ensure the treatment, dimethicone lotion is repeated a week later and on day 14 the final result is evaluated.
Category
Treatment - Drugs
2
Description
To prepare the decoction, 10 g of dried Allium Sativum (equivalent to a medium Allium Sativum cube with a pin hole then dried) with 20 g of dried Mentha Pulegium (leaves and stems) in 1.5 cups of water for 10 minutes. Boil for 15 minutes until it reaches a glass, then is kept in a clear glass container and refrigerated in a glass container for a week. After parental consent for their child to be included in the research project, to determine the susceptibility to decoction of Allium Sativum and Mentha Pulegium, some of the product is rubbed on the back of the hair, if no severe allergic symptoms (asthma or contact dermatitis) occur. Use is intended. How to use boiled by the researcher Parents are taught as follows: In this group, after selecting the research units, after washing their hair with ordinary shampoo and hair dehydration, the desired boiling on the scalp And the wet hair is rubbed enough to account for the length of the hair and then shine for 10 minutes (13). The same procedure is repeated a week later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls' schools
Full name of responsible person
maryam paricheh
Street address
No. 583, Ghaem7 Ave., Ghaem Street., Ganbarabad Town
City
gonabad
Province
Razavi Khorasan
Postal code
9691186415
Phone
+98 51 5725 5965
Email
Mparicheh15@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
dr Shahla Khosravan
Street address
Gonabad, Asian Road Margin
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
khosravan@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Gonabad medical university
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
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Paricheh
Position
MSc Student Community Health Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 583, Ghaem7 Ave., Ghaem Street., Ganbarabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691186415
Phone
+98 51 5725 5965
Fax
Email
Mparicheh15@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Paricheh
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 583, Ghaem7 Ave., Ghaem Street., Ganbarabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691186415
Phone
+98 51 5725 5965
Email
Mparicheh15@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Paricheh
Position
MSc Student Community Health Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 583, Ghaem7 Ave., Ghaem Street., Ganbar abad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691186415
Phone
+98 51 5725 5965
Fax
Email
Mparicheh15@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