Due to the high incidence of head lice in school-age children and reports of lice resistance to existing treatments, in this study, a decoction of peganum harmala seeds was used to treat head lice. The use of this treatment method has been confirmed in traditional Iranian medicine books.
Design
The total sample size is 50 people who are randomly divided into two groups of 25 intervention and control. It should be noted that due to the different packaging of the two products, it is not possible to blind, but the treatment is done randomly so that neither the patient nor the researcher can influence the choice of drug. Also, statistical analysts are unaware of the treatment groups until the end of the study
Settings and conduct
Patients are visited in Baze Sheikh Health Center and the severity of the disease is diagnosed (mild <10, 20> moderate> 10, severe> 20). If there is at least one live lice and its eggs are randomly entered in the intervention and received treatment.
Participants/Inclusion and exclusion criteria
Participants are children in the age range of 3-12 years who have seen at least one live lice and live eggs and have not received treatment in the past week. If the hair length is shorter than 3 cm and also there is an open wound on the head and no referral for follow-up or dissatisfaction to participate in the study will be prevented from entering the study.
Intervention groups
Patients are divided into control and intervention groups who will receive the usual treatment of permethrin as a control group and treatment with peganum harmala decoction as an intervention group.
Main outcome variables
Patients are examined on the first, second, sixth, seventh, and fifteenth days of the study. Evaluation of treatment based on the absence or presence of adult lice or their eggs as well as its severity will be recorded based on initial observations.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201219049760N1
Registration date:2021-07-30, 1400/05/08
Registration timing:prospective
Last update:2021-07-30, 1400/05/08
Update count:0
Registration date
2021-07-30, 1400/05/08
Registrant information
Name
Motahhreh Bouzari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 3372
Email address
bouzarim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of standard decoction of Peganum harmala seeds on children head lice treatment
Public title
Investigation the effect of Peganum harmala decoction on head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children between 3-12 years old referred to Baze Sheikh Health Center with pediculosis diagnose by a dermatologist: At the study beginning, at least 3 adult lice or at least 1 adult lice and 10 lice eggs should be seen in the patient's hair.
Obtaining the informed consent of the patient / parents
The patient's hair length should be at least 3 cm
Patient/parents consent of not using any chemical, plant or other anti - louse treatment during the study
Exclusion criteria:
Lack of patient/parents consent to participate in study
Failing at follow-up and follow-up visits
Children with age less than 3 years or over 12
Just lice egg are exist in patient’s hair not adult lice
Patient’s hair cutting below 3 cm length
Using from other anti-lice treatment in the last 7 days
Taking antibiotics in the last 7 days
Open wound existence in the patient's head
Existence of any type of underlying scalp disease (other than lice) at the study beginning (such as psoriasis)
Age
From 3 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization
Randomization tool: https://www.sealedenvelope.com/ How to make a random sequence: To perform this method, the number of intervention groups (two groups A and B), the volume of each block (6 in each block) and the number of sample size (90 patients) were entered into the website. The site then provided a list of 15 blocks, each contains 6 patients. In this study, we use 6 patients in each block and the website randomizes and numbers the blocks. Allocation Concealment Method: Sealed Envelopes
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 Mashhad University of Medical Sciences
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2020-11-07, 1399/08/17
Ethics committee reference number
IR.MUMS.REC.1399.487
Health conditions studied
1
Description of health condition studied
Pediculosis
ICD-10 code
B85.0
ICD-10 code description
Pediculosis due to Pediculus humanus capitis
Primary outcomes
1
Description
Lice eradication rate
Timepoint
Observation of live lice at baseline and on days 2, 6, 7 and 14 after treatment
Method of measurement
By physical examination on specified days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive standardized pewter spray based on alkaloid Harmine once at the beginning of diagnosis and after one week.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive standard lice treatment using 1% permethrin shampoo once at the beginning of diagnosis and after one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bazeh Sheykh clinic
Full name of responsible person
Mohaddese Beyki
Street address
No. 35, Poursina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
915987785
Phone
+98 51 3375 6078
Email
bazesheykh2018@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqqodi
Street address
Mashhad university of medical science, Azadi Sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3879 5031
Fax
+98 51 3871 3638
Email
Info.en@mums.ac.ir
Web page address
https://www.mums.ac.ir/index.php/en/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zohreh malekirad
Position
pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Unit4, First Floor, No.19, Ebne sina 1 St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9136736479
Phone
+98 51 3852 9665
Email
malekirz941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
motahare bouzari
Position
Assistant Professor of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
bouzarim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
مطهره بوذری
Position
Assistant Professor of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
bouzarim@mums.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the study, the results will be published as an article and all data will be published as supplement.
When the data will become available and for how long
Access starts 6 months after article publication
To whom data/document is available
everybody who have access to the article
Under which criteria data/document could be used
References to study results are permitted.
From where data/document is obtainable
Send email to the corresponding author
What processes are involved for a request to access data/document
Documents will be sent 1 to 3 months after sending the email to the corresponding author.