Comparison the effectiveness of herbal product of “peganum harmala” and Permethrin1%in treatment of pediculus capitis patient in referrals to health center of Karaj city.
Comparison of the Effect of Traditional Oils Oil with Shampoo Permethrin 1% on Head Lice Treatment Referring to Karaj Health Center
Design
A clinical trial with community based and pragmatic control group, without blindness, is randomized
Settings and conduct
Health center of Karaj city
Participants/Inclusion and exclusion criteria
Criteria for entering the study
1- Diagnosis of head lice by the expert or doctor of the health center and confirmed by the researcher
2. Satisfaction of the patient or his parents from entering the plan
3. No drug or therapeutic treatment for head lice in the last 4 weeks
Non-entry criteria
1. Pregnant woman
2- People with skin lesions on the scalp
3. Children under two years old
Intervention groups
Esfand oil group; Permethrin shampoo group
Main outcome variables
Time to examine symptoms; side effects; reply to treatment; severity of symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170825035890N1
Registration date:2018-04-28, 1397/02/08
Registration timing:registered_while_recruiting
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Mina Maarefvand
Name of organization / entity
Iran medical univercity
Country
Iran (Islamic Republic of)
Phone
+98 26 3460 8945
Email address
maarefvand@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of herbal product of “peganum harmala” and Permethrin1%in treatment of pediculus capitis patient in referrals to health center of Karaj city.
Public title
Effectiveness of “peganum harmala” in treatment of pediculus capitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of head lice by an expert or doctor at a health center and approved by a researcher
Satisfaction of the patient or his parents from entering the plan
No drug or treatment for head lice treatment over the past 4 weeks
Exclusion criteria:
Pregnant lady
People with skin lesions on the scalp
Children under two years old
Age
From 2 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done stratified randomization.
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 Iran University of Medical Sciences
Street address
Hafez Street - Behesht Street - Faculty of Traditional Medicine
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-18, 1396/12/27
Ethics committee reference number
IR.IUMS.REC 1396.9321309006
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
Mature nest, lice egg
Timepoint
The first, second, third and eighth day of the onset of treatment
Method of measurement
Mature insect count and lice egg
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, two vials each containing 20cc oil esfand is given to be used according to the order. The consumption of oil is such that at the start of treatment 3 days (once a day) and every time the hair and scalp are smeared with oil and rinse after 20 minutes and one week later, the treatment is repeated in the same way.. Both groups emphasize that the drug should be used on dry and clean hair. In both groups, other family members are treated according to the first course of treatment case of family members, the likelihood of reinfection in both groups' decreases. Also, other health care needed to accelerate the treatment process (Including washing, sunbathing, and combing) both groups are trained and stressed to be done. Effect of treatment on the first, second and third days of the onset of the initial dose and one day after the end of the second stage, the treatment was performed with a face examination.
Category
Treatment - Drugs
2
Description
Control group: The other group is given the permethrin shampoo which is used once a day at the start of treatment and once a week later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Karaj city
Full name of responsible person
Mina Maarefvand
Street address
Hafez Street - Behesht Street - Faculty of Traditional Medicine
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
+98 21 86701
Email
maarefvand@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Horiyeh Mohammadi Konari
Street address
Hafez Street - Behesht Street - Faculty of Traditional Medicine
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
maarefvand@tak.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mina Maarefvand
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Hafez Street - Behesht Street - Faculty of Traditional Medicine
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
maarefvand@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mina Maarefvand
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Hafez Street - Behesht Street - Faculty of Traditional Medicine
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
maarefvand@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mina Maarefvand
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Hafez Street - Behesht Street - Faculty of Traditional Medicine
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
maarefvand@tak.iums.ac.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
Original outcome data
When the data will become available and for how long
Since 2020
To whom data/document is available
For researchers working in academic and scientific institutions and industry professionals
Under which criteria data/document could be used
No special circumstances
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Receive email, study by researcher within two weeks, answering