The purpose of current study is assessment of red beet extract effectiveness on lice, nit and itch decline in Head Pediculosis suffering patients.
Design
A number of 280 patients who suffer from Head Pediculosis and meet the study inclusion qualifications and are clients of Ardakan city main health centers are selected as samples for current study. Participants are randomly divided into two groups via envelopes containing numbers. Control group are treated by Permethrin while the other by red beet extract. 24 hours after application its therapeutic effect is evaluated.
Settings and conduct
This study is considered as a clinical trial one being conducted in Ardakan main health centers affiliated to Ardakan Health Network. Patients who are suffering from Head Pediculosis and meet the inclusion qualifications are studied as samples. The mentioned patients are required to apply delivered medicine while being prohibited from taking any other medicine until 24 hours. Members of control group are given Permethrin while red beet extract for intervening group. After 24 hours of treatment, patients are evaluated in terms of three variables of lice, nit and degree of itching.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having Head Pediculosis
Exclusion criteria: having intense skin disease such as Eczema, Psoriasis and Chronic Dermatitis.
Intervention groups
Red beet extract is applied in intervening group while Permethrin in control group
Main outcome variables
Number of lice, nit and severity of itching is evaluated after one day via a questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171016036803N1
Registration date:2017-12-28, 1396/10/07
Registration timing:registered_while_recruiting
Last update:2017-12-28, 1396/10/07
Update count:0
Registration date
2017-12-28, 1396/10/07
Registrant information
Name
Habib Hemat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 3717
Email address
h.hemat@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid sadoghi university ofmedical science
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of red beet extract effectiveness on Head Pediculosis treatment in comparison with Permethrin 1%
Public title
Assessment of red beet extract impact on Head Pediculosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being a health centers client.
Having Head Pediculosis.
Agree on treatment by red beet extract.
Exclusion criteria:
While having wound on scalp
While suffering from Head Psoriasis
While suffering from chronic Dermatitis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
280
Actual sample size reached:
280
Randomization (investigator's opinion)
Randomized
Randomization description
A sample of 280 patients were randomly selected using numbered envelopes containing labels which was already done. Samples were divided into two groups of the patients under treatment by Permethrin (140) and the ones under treatment by red beet extract (140).
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 Yazd University of Medical Sciences
Street address
Central department of Shahid sadoughei medical university, Shahid bahonar square, Yazd
City
Yazd
Province
Yazd
Postal code
89169784477
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SSU.REC.1395.237
Health conditions studied
1
Description of health condition studied
Pediculosis
ICD-10 code
B85
ICD-10 code description
Head-louse infestation.
Primary outcomes
1
Description
Observing alive lice
Timepoint
Before treatment- 1 day after treatment.
Method of measurement
Counting number of alive lice by specialist.
2
Description
Observing lace hat stick to the hair
Timepoint
Before tratment- 1 day after treatment.
Method of measurement
Count the number of lice hat in 25 centimeters of head
Secondary outcomes
1
Description
Drug side effects
Timepoint
24 houres after treatment
Method of measurement
Observation the effect
Intervention groups
1
Description
Intervention group: Red beta vulgaris juice (once for an hour)
Category
Treatment - Drugs
2
Description
Control group: Shampoo Permethrin 1% (once for ten minutes)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Ardakan
Full name of responsible person
Habib Hemat
Street address
Imam Khomeinee Street, Ardakan Health Network
City
Ardakan
Province
Yazd
Postal code
8951737915
Phone
+98 35 3223 8915
Email
h.hemat@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Central department of Shahid sadoughei medical university, Shahid bahonar square, Yazd
City
Yazd
Province
Yazd
Postal code
89169784477
Phone
+98 35 3724 0171
Email
h.hemat@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Habib Hemat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Central department of Shahid sadoughei medical university, Shahid bahonar square,Yazd
City
Yazd
Province
Yazd
Postal code
89169784477
Phone
+98 35 3724 0171
Fax
Email
h.hemat@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Central department of Shahid sadoughei medical university, Shahid bahonar square, Yazd
City
Yazd
Province
Yazd
Postal code
89169784477
Phone
+98 35 3724 0171
Fax
Email
dr.emtiazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Habib Hemat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Central department of Shahid sadoughei medical university, Shahid bahonar square, Yazd
City
Yazd
Province
Yazd
Postal code
89169784477
Phone
+98 35 3724 0171
Fax
Email
h.hemat@ssu.ac.ir
Web page address
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
the sponsor of this study have not permited.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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