Evaluation of the effects of ozonated olive oil on the treatment of head lice by in vivo Design: The population of the study was 120 patients with head lice who visited Mashhad's clinics and in addition to confirmation of the disease by the physician, the company's satisfaction form in this study Have signed up. How to do: Patients divided into two groups of 60 divided into the first group, in addition to the usual treatment (permotherm shampooing), ozonated olive oil and the second group under common treatment (using permotherm shampoos). At the end of the study period, the two groups will compare and test the response to treatment. Interventions: The intervention group emulsifies the oil for seven days and daily for two hours each day for oily olive oil. And then it is washed with a regular shampoo (shampoo for baby hair). Main outcome variables: a) Primary outcome: presence of live lice in the hair, and examination of live lice on the third and seventh days. (B) Secondary outcome: the presence of lambs in the hair and counting the number of eggs adhering to the hair at 25 centimeters Square meters on the first, third and seventh day of treatment.
General information
Acronym
anti-lice effect of ozonated olive oil
IRCT registration information
IRCT registration number:IRCT2017100936672N1
Registration date:2017-11-14, 1396/08/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-14, 1396/08/23
Registrant information
Name
omid rajabi
Name of organization / entity
university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 3483
Email address
rajabio@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-14, 1396/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anti-lice effect of topical lotion of ozonated olive oil and comparison of its effect with permethrin shampoo
Public title
Evaluation of anti-lice effect of topical lotion of ozonated olive oil and comparison of its effect with permethrin shampoo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Lice in the head; Filling out the consent form; Carrying out the clinical work by the patient.
Exclusion criteria: No referral for follow up; Unwillingness to cooperate for any reason.
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
mashhad university of medical sciences
Street address
ghoreishi department- daneshgah st.
City
mashhad
Postal code
13944-91388
Approval date
2010-10-09, 1389/07/17
Ethics committee reference number
IR.MUMS.SP.1396. 168
Health conditions studied
1
Description of health condition studied
pediculosis
ICD-10 code
B85.0 Pedi
ICD-10 code description
Head-louse infestation
Primary outcomes
1
Description
observing alive lice
Timepoint
before treatment- 3 days after treatment-1 week after treatment
Method of measurement
counting number of alive lice by specialist
Secondary outcomes
1
Description
observing lace hat stick to the hair
Timepoint
before tratment- 3 days after treatment- 1 week after treatment
Method of measurement
Count the number of lice hat in 25 centimeters of head
Intervention groups
1
Description
Control group:
In this group, permethrin shampoo is used as the standard of treatment
Category
Treatment - Drugs
2
Description
Intervention group:
In this group, in addition to the use of permethrin in a routine and common, ozonated olive oil is used daily as an international agent.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Parasitology, Imam Reza Hospital
Full name of responsible person
dr. fariba berenji
Street address
Imam Reza Hospital
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
mashhad university of medical sciences
Full name of responsible person
dr. fariba berenji
Street address
Department of Parasitology, Imam Reza Hospital
City
mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
pharmacy school of mashhad
Full name of responsible person
dr. omid rajabi
Position
associated prof.
Other areas of specialty/work
Street address
pharmacy school of mashhad- ferdowsi university of mashhad- park sq.
City
mashhad
Postal code
Phone
+98 51 3180 1126
Fax
Email
rajabio@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
pharmacy school of mashhad
Full name of responsible person
dr. omid rajabi
Position
pharmaceutics
Other areas of specialty/work
Street address
pharmacy school of mashhad- ferdowsi university of mashhad- park sq.
City
mashhad
Postal code
Phone
+98 51 3180 1126
Fax
Email
rajabio@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
pharmacy school of mashhad
Full name of responsible person
atoosa haghighizadeh
Position
M.S.
Other areas of specialty/work
Street address
pharmacy school of mashhad
City
mashhad
Postal code
Phone
+98 51 3180 1126
Fax
Email
atoosa.hz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)