1 - Determine the severity of the contamination with head lice (nit or live lice), before receiving the Rhus coriaria product
2. Determine the severity of the contamination with head lice (nit or live lice), after receiving the Rhus coriaria product
3. Determine rate of head pruritus before receiving the Rhus coriaria product
4 - Determine rate of head pruritus after receiving the Rhus coriaria product
5 - Comparison of the severity of the contamination with head lice (nit or live lice) before and after receiving the Rhus coriaria product
6 - Comparison of the rate of head pruritus before and after receiving the Rhus coriaria product
Design
A clinical trial that has a group and intervention for everyone is the same
Settings and conduct
This is a clinical trial which is carried out at Fardis Health Centers. Patients with head lice and Inclusion criteria entire in the study. Patients only use the drug that they are given. On the 4th, 10th, and 14th days after treatment, Patients are evaluated for lice, nit and degree of itching.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Take at least two continuous period of permethrin, according to the correct instruction and having at least grade one (5-9 nit or live lice) according to severity of the contamination
Exclusion criteria :Sensitivity to product, Head skin ulcers, Secondary skin infection including Impetigo and chronic skin disease such as Psoriasis, Immunodeficiency, Pregnancy; Participation in any clinical trial within the past 4 weeks; Use less than twice in every three consecutive days, The concomitant use of another anti-lice drugs
Intervention groups
Group of users of Rhus coriaria product
Main outcome variables
Number of lice, nit and severity of itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180712040446N1
Registration date:2018-07-22, 1397/04/31
Registration timing:registered_while_recruiting
Last update:2018-07-22, 1397/04/31
Update count:0
Registration date
2018-07-22, 1397/04/31
Registrant information
Name
Atefe Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2247 3630
Email address
atf.sharif@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of topical product of Rhus coriaria on head lice
Public title
Efficacy of topical product of Rhus coriaria on head lice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Take at least two continuous period of permethrin, according to the correct instruction
Having at least grade one (5-9 nit or live lice) according to severity of the contamination
Exclusion criteria:
Sensitivity to product
Head skin ulcers
Secondary skin infection including Impetigo
Chronic skin disease such as Psoriasis
Immunodeficiency
Pregnancy
Participation in any clinical trial within the past 4 weeks
Use less than twice in every three consecutive days
The concomitant use of another anti-lice drugs
Age
From 2 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences and Health Services
At the beginning of the intervention, 4, 10, and 14 days after the start of the Rhus coriaria product
Method of measurement
Mature insect count and lice egg
Secondary outcomes
1
Description
Pruritus rate
Timepoint
At the beginning of the intervention, 4, 10, and 14 days after the start of the Rhus coriaria product
Method of measurement
Ask the patient
Intervention groups
1
Description
The study will be conducted as a before and after clinical trial . In intervention group, for each patient, 60 cc of Rhus coriaria product, sprayed for three continuous days, 20 cc daily with a plastic brush tiny teeth will be given. The patient should massage each time for 10 minutes on the head and then wrap around a hair a towel and wait for 90 minutes. Then comb with a fine brush. Again 60 cc of the drug is given for use in three continuous days on the seventh, eighth and ninth days. Other family members are treated simultaneously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center of Fardis city
Full name of responsible person
Atefe Sharif
Street address
Center for Health Services of Shohadaye Meshkindasht ,Pasgah Street ,Meshkin Dasht ,Fardis , Alborz
City
Fardis
Province
Alborz
Postal code
3174665538
Phone
+98 26 3620 3030
Email
atf.sharif@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research,Traditional Medicine School,Shahid Beheshti University
Full name of responsible person
Somaye Esmaili
Street address
No.8 Shams Alley,Opposite Tavarnir Street - Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research,Traditional Medicine School,Shahid Beheshti 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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefe Sharif
Position
Ph.D Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 ,Shams,Opposite Tavarnir Alley - Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
atf.sharif@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmouud Khodadost
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8,Shams,Opposite Tavarnir Alley - Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
mkhodadoost@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefe Sharif
Position
Ph.D Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 ,Shams,Opposite Tavarnir Alley - Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
atf.sharif@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD